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- Recall Enforcement Event ID: 84546
Recall Enforment Report D-0743-2020
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Assurance Infusion, originally initiated on 12-20-2019 for the product HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 The product was recalled due to lack of sterility assurance.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0743-2020 | 12-20-2019 | 01-22-2020 | Class II | 4 syringes | HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0711-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0691-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0754-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0730-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0712-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0667-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0750-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0666-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0701-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0738-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0725-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0675-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0769-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0676-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0772-2020 | 12-20-2019 | 01-22-2020 | Class II | 166 vials | TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0689-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringe | BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0696-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0692-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0776-2020 | 12-20-2019 | 01-22-2020 | Class II | 358 vials | TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0662-2020 | 12-20-2019 | 01-22-2020 | Class II | 60 vials | Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0773-2020 | 12-20-2019 | 01-22-2020 | Class II | 1290 vials | TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0678-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0732-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0747-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0763-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800 | Lack of sterility assurance. | Terminated |
D-0779-2020 | 12-20-2019 | 01-22-2020 | Class II | 45 vials | TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0736-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 vials | HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 | Lack of sterility assurance. | Terminated |
D-0668-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0699-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0759-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0722-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0720-2020 | 12-20-2019 | 01-22-2020 | Class II | 19 vials | CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0718-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0715-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0753-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0728-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringe | FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0716-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0765-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0688-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0778-2020 | 12-20-2019 | 01-22-2020 | Class II | 20 vials | TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0704-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0723-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0758-2020 | 12-20-2019 | 01-22-2020 | Class II | 3 syringes | MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0755-2020 | 12-20-2019 | 01-22-2020 | Class II | 3 syringes | MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0710-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0756-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0764-2020 | 12-20-2019 | 01-22-2020 | Class II | 190 vials | QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0681-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0686-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0683-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0724-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0739-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0682-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0729-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0694-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0714-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0762-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0721-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0693-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0697-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0672-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0717-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0768-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800 | Lack of sterility assurance. | Terminated |
D-0670-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0719-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0695-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0741-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0766-2020 | 12-20-2019 | 01-22-2020 | Class II | 134 vials | QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0748-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0663-2020 | 12-20-2019 | 01-22-2020 | Class II | 32 droppers | Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0757-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0735-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 vials | HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0745-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0709-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0698-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0685-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0740-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0752-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0702-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0700-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0761-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0679-2020 | 12-20-2019 | 01-22-2020 | Class II | 28 vials | BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0731-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0708-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0706-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0703-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0742-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0771-2020 | 12-20-2019 | 01-22-2020 | Class II | 7 vials | TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0705-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0746-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0774-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 vial | TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0713-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0777-2020 | 12-20-2019 | 01-22-2020 | Class II | 10 vials | TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0707-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0684-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0760-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0737-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0733-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0665-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0749-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes/1 vial | LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0770-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0671-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0674-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0664-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800 | Lack of sterility assurance. | Terminated |
D-0673-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0690-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0669-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0680-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0775-2020 | 12-20-2019 | 01-22-2020 | Class II | 10 vials | TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0687-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0677-2020 | 12-20-2019 | 01-22-2020 | Class II | 15 vials | Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0726-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0767-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0734-2020 | 12-20-2019 | 01-22-2020 | Class II | 5 vials | HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0751-2020 | 12-20-2019 | 01-22-2020 | Class II | 4 syringes | MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0727-2020 | 12-20-2019 | 01-22-2020 | Class II | 1 syringe | FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
D-0744-2020 | 12-20-2019 | 01-22-2020 | Class II | 2 syringes | HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated |
Recall Enforcement Report D-0743-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0743-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12112019@1 Exp. 12/20/2019; 12112019@6 Exp. 12/20/2019; 12162019@23 Exp. 12/25/2019; 12172019@7 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0711-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0711-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12112019@5 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0691-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0691-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12172019@5 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0754-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0754-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@31 Exp. 12/21/2019; 12172019@8 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0730-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0730-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@11 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0712-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0712-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12102019@6 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0667-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0667-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12102019@8 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0750-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0750-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@9 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0666-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0666-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@20 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0701-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0701-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@11 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0738-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0738-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@12 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0725-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0725-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@15 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0675-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0675-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@2 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0769-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0769-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@19 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0676-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0676-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@18 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0772-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0772-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 166 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0689-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0689-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@4 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0696-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0696-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@15 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0692-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0692-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@28 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0776-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0776-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 358 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0662-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0662-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 60 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0773-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0773-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1290 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 07082019@29 Exp. 01/04/2020; 06252019@11 Exp. 12/22/2019; 07082019@29 Exp. 01/04/2020; 06252019@6 Exp. 12/22/2019; 07082019@28 Exp. 01/04/2020; 07262019@3 Exp. 01/22/2020; 07102019@13 Exp. 01/06/2020; 07162019@13 Exp. 01/12/2020; 07242019@15 Exp. 01/20/2020; 07162019@12 Exp. 01/12/2020; 08272019@11 Exp. 02/23/2020; 08162019@6 Exp. 02/12/2020; 07312019@14 Exp. 01/27/2020; 07262019@4 Exp. 01/22/2020; 08152019@9 Exp. 02/11/2020; 08162019@6 Exp. 02/12/2020; 08092019@6 Exp. 02/05/2020; 07312019@15 Exp. 01/27/2020; 08092019@5 Exp. 02/05/2020; 08272019@12 Exp. 02/23/2020; 09032019@36 Exp. 03/01/2020; 10012019@19 Exp. 03/30/2020; 09162019@15 Exp. 03/14/2020; 09162019@14 Exp. 03/14/2020; 09032019@35 Exp. 03/01/2020; 09032019@35 Exp. 03/01/2020; 09242019@15 Exp. 03/22/2020; 09112019@5 Exp. 03/09/2020; 10022019@15 Exp. 03/30/2020; 09112019@4 Exp. 03/09/2020; 10162019@16 Exp. 04/13/2020; 10282019@21 Exp. 04/25/2020; 10212019@20 Exp. 03/04/2020; 10162019@15 Exp. 04/13/2020; 10282019@22 Exp. 04/25/2020; 10242019@6 Exp. 03/04/2020; 10232019@25 Exp. 03/04/2020 Exp. 10082019@4 Exp. 04/05/2020; 10082019@5 Exp. 04/05/2020; 11262019@26 Exp. 01/10/2020; 12032019@12 Exp. 01/17/2020; 11262019@25 Exp. 01/10/2020; 10302019@24 Exp. 04/27/2020; 11262019@27 Exp. 01/10/2020; 10302019@23 Exp. 04/27/2020; 12032019@11 Exp. 01/17/2020; 11042019@10 Exp. 03/04/2020; 11042019@10 Exp. 03/04/2020; 11262019@24 Exp. 01/10/2020; 12042019@14 Exp. 01/18/2020; 12042019@15 Exp. 01/18/2020; 12102019@14 Exp. 01/24/2020; 12102019@13 Exp. 01/24/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0678-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0678-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 07302019@15 Exp. 01/29/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0732-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0732-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@14 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0747-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0747-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@9 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0763-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0763-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 07012019@30 Exp. 12/28/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0779-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0779-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 45 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0736-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0736-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 11272019@31 Exp. 12/31/2019; 12022019@19 Exp. 01/05/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0668-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0668-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12172019@3 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0699-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0699-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@3 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0759-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0759-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@7 Exp. 12/21/2019; 12162019@27 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0722-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0722-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@8 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0720-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0720-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 19 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 08212019@29 Exp. 02/17/2020; 07152019@12 Exp. 01/11/2020; 07082019@26 Exp. 01/04/2020; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0718-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0718-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@5 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0715-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0715-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12162019@6 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0753-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0753-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@30 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0728-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0728-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@18 Exp. 12/21/2019; 12162019@24 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0716-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0716-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@12 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0765-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0765-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 08132019@15 Exp. 02/09/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0688-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0688-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@10 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0778-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0778-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 20 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 07032019@12 Exp. 12/30/2019; 08212019@32 Exp. 02/17/2020; 10032019@12 Exp. 03/31/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0704-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0704-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@18 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0723-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0723-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@22 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0758-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0758-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12112019@24 Exp. 12/20/2019; 12122019@1 Exp. 12/21/2019; 12122019@2 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0755-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0755-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12102019@7 Exp. 12/19/2019; 12112019@11 Exp. 12/20/2019; 12162019@5 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0710-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0710-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12182019@7 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0756-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0756-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@20 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0764-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0764-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 190 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 07012019@30 Exp. 12/28/2019; 08052019@13 Exp. 02/01/2020; 09252019@15 Exp. 03/23/2020; 10292019@12 Exp. 04/26/2020; 10092019@6 Exp. 03/04/2020; 10162019@12 Exp. 04/13/2020; 12042019@31 Exp. 01/18/2020; 12162019@35 Exp. 01/30/2020; 11262019@37 Exp. 05/24/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0681-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0681-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@8 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0686-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0686-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@20 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0683-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0683-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@6 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0724-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0724-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@21 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0739-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0739-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@3 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0682-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0682-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@4 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0729-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0729-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12182019@3 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0694-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0694-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@8 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0714-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0714-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@21 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0762-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0762-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 10142019@14 Exp. 01/12/2020; 11042019@8 Exp. 02/02/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0721-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0721-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@24 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0693-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0693-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12172019@10 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0697-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0697-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@10 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0672-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0672-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@16 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0717-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0717-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12182019@4 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0768-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0768-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@9 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0670-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0670-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12102019@2 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0719-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0719-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12172019@13 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0695-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0695-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12182019@1 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0741-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0741-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@9 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0766-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0766-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 134 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/2020; 11272019@24 Exp. 01/22/2020; 09182019@18 Exp. 03/16/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0748-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0748-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0663-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0663-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 32 droppers Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12092019@33 Exp. 03/08/2020; 11112019@30 Exp. 02/09/2020; 10012019@17 Exp. 12/30/2019; 10162019@18 Exp. 01/14/2020; 10252019@11 Exp. 01/23/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0757-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0757-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12132019@6 Exp. 12/22/2019; 12182019@5 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0735-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0735-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12162019@38 Exp. 01/16/2020; 11272019@32 Exp. 12/31/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0745-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0745-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12182019@6 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0709-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0709-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12172019@4 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0698-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0698-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@27 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0685-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0685-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12182019@2 Exp. 12/27/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0740-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0740-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@7 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0752-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0752-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@19 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0702-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0702-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12202019@1 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0700-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0700-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@23 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0761-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0761-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@21 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0679-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0679-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 28 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 11132019@15 Exp. 02/11/2020; 12112019@25 Exp. 02/13/2020; 11202019@9 Exp. 02/13/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0731-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0731-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@30 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0708-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0708-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12102019@5 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0706-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0706-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12162019@28 Exp. 12/25/2019; 12102019@1 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0703-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0703-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@17 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0742-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0742-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@17 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0771-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0771-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 08212019@17 Exp. 02/17/2020; 10232019@23 Exp. 04/20/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0705-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0705-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@1 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0746-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0746-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@4 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0774-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0774-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 vial Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 11042019@28 Exp. 05/02/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0713-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0713-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12122019@26 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0777-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0777-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 08302019@4 Exp. 02/26/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0707-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0707-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12102019@4 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0684-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0684-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@5 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0760-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0760-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@19 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0737-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0737-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@4 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0733-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0733-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12132019@1 Exp. 12/22/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0665-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0665-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@23 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0749-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0749-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes/1 vial Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 09172019@18 Exp. 03/15/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0770-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0770-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 10242019@7 Exp. 04/21/2020; 10032019@11 Exp. 03/31/2020; 11042019@12 Exp. 05/02/2020; 09242019@9 Exp. 03/22/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0671-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0671-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12172019@6 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0674-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0674-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@27 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0664-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0664-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12172019@2 Exp. 12/26/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0673-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0673-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12202019@2 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0690-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0690-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12102019@3 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0669-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0669-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12112019@7 Exp. 12/20/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0680-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0680-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@29 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0775-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0775-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 07082019@31 Exp. 01/04/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0687-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0687-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@25 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0677-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0677-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 15 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 09192019@19 Exp. 03/17/2020; 08162019@5 Exp. 02/12/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0726-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0726-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@8 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0767-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0767-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12162019@26 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0734-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0734-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0751-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0751-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@13 Exp. 12/21/2019; 12172019@9 Exp. 12/26/2019; 12122019@10 Exp. 12/21/2019; 12162019@13 Exp. 12/25/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0727-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0727-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 syringe Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lot: 12122019@3 Exp. 12/21/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0744-2020
- Event ID
- 84546 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0744-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Reason For Recall
- Lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-22-2020
- Recall Initiation Date
- 12-20-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 10-27-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Assurance Infusion
- Code Info
- Lots: 12162019@14 Exp. 12/25/2019; 12102019@19 Exp. 12/19/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.