Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0673-2020 | 12-20-2019 | BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0669-2020 | 12-20-2019 | 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. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0690-2020 | 12-20-2019 | BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0766-2020 | 12-20-2019 | QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 134 vials | Class II | Terminated |
| D-0713-2020 | 12-20-2019 | BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0663-2020 | 12-20-2019 | Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 32 droppers | Class II | Terminated |
| D-0695-2020 | 12-20-2019 | BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0735-2020 | 12-20-2019 | HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 vials | Class II | Terminated |
| D-0777-2020 | 12-20-2019 | TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 10 vials | Class II | Terminated |
| D-0709-2020 | 12-20-2019 | BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0684-2020 | 12-20-2019 | BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0752-2020 | 12-20-2019 | MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0760-2020 | 12-20-2019 | MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0700-2020 | 12-20-2019 | BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0707-2020 | 12-20-2019 | BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0685-2020 | 12-20-2019 | BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0737-2020 | 12-20-2019 | HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0679-2020 | 12-20-2019 | BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 28 vials | Class II | Terminated |
| D-0733-2020 | 12-20-2019 | FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0708-2020 | 12-20-2019 | BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0665-2020 | 12-20-2019 | BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0703-2020 | 12-20-2019 | BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0771-2020 | 12-20-2019 | TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 7 vials | Class II | Terminated |
| D-0746-2020 | 12-20-2019 | HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0670-2020 | 12-20-2019 | BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0686-2020 | 12-20-2019 | BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0683-2020 | 12-20-2019 | BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0724-2020 | 12-20-2019 | CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0704-2020 | 12-20-2019 | BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0723-2020 | 12-20-2019 | CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0758-2020 | 12-20-2019 | MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 3 syringes | Class II | Terminated |
| D-0755-2020 | 12-20-2019 | MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 3 syringes | Class II | Terminated |
| D-0710-2020 | 12-20-2019 | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0756-2020 | 12-20-2019 | MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0764-2020 | 12-20-2019 | QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 190 vials | Class II | Terminated |
| D-0681-2020 | 12-20-2019 | BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0730-2020 | 12-20-2019 | FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0662-2020 | 12-20-2019 | Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 60 vials | Class II | Terminated |
| D-0711-2020 | 12-20-2019 | BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0692-2020 | 12-20-2019 | BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0754-2020 | 12-20-2019 | MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0712-2020 | 12-20-2019 | BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0773-2020 | 12-20-2019 | TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1290 vials | Class II | Terminated |
| D-0667-2020 | 12-20-2019 | BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0678-2020 | 12-20-2019 | Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 5 vials | Class II | Terminated |
| D-0750-2020 | 12-20-2019 | MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0732-2020 | 12-20-2019 | FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0689-2020 | 12-20-2019 | 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. | Assurance Infusion / 2 syringe | Class II | Terminated |
| D-0743-2020 | 12-20-2019 | HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 4 syringes | Class II | Terminated |
| D-0696-2020 | 12-20-2019 | BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0691-2020 | 12-20-2019 | BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0776-2020 | 12-20-2019 | TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 358 vials | Class II | Terminated |
| D-0676-2020 | 12-20-2019 | BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0675-2020 | 12-20-2019 | 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. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0738-2020 | 12-20-2019 | HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0666-2020 | 12-20-2019 | BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0725-2020 | 12-20-2019 | CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0763-2020 | 12-20-2019 | QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800 | Lack of sterility assurance. | Assurance Infusion / 5 vials | Class II | Terminated |
| D-0769-2020 | 12-20-2019 | SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0779-2020 | 12-20-2019 | TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 45 vials | Class II | Terminated |
| D-0701-2020 | 12-20-2019 | BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0747-2020 | 12-20-2019 | HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0772-2020 | 12-20-2019 | TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 166 vials | Class II | Terminated |
| D-0736-2020 | 12-20-2019 | HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 vials | Class II | Terminated |
| D-0668-2020 | 12-20-2019 | BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0759-2020 | 12-20-2019 | MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0722-2020 | 12-20-2019 | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0720-2020 | 12-20-2019 | CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 19 vials | Class II | Terminated |
| D-0718-2020 | 12-20-2019 | BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0699-2020 | 12-20-2019 | BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0715-2020 | 12-20-2019 | BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0728-2020 | 12-20-2019 | FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringe | Class II | Terminated |
| D-0716-2020 | 12-20-2019 | BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0765-2020 | 12-20-2019 | QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 5 vials | Class II | Terminated |
| D-0688-2020 | 12-20-2019 | BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0778-2020 | 12-20-2019 | TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 20 vials | Class II | Terminated |
| D-0753-2020 | 12-20-2019 | MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0634-2020 | 12-20-2019 | PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397. | Superpotent Drug: Salicylic acid content is above the firm's specification. | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 2542 units | Class III | Terminated |
| D-0833-2020 | 12-20-2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1. Package NDCs: 51672-4130-6; 51672-4130-4; 51672-4130-1; 51672-4130-3; 51672-4130-0; 51672-4131-6; 51672-4131-4; 51672-4131-1; 51672-4131-3; 51672-4131-0; 51672-4132-6; 51672-4132-4; 51672-4132-1; 51672-4132-2; 51672-4132-3; 51672-4132-0; 51672-4133-6; 51672-4133-4; 51672-4133-1; 51672-4133-2; 51672-4133-3; 51672-4133-0 | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. | Taro Pharmaceuticals U.S.A., Inc. / | Class I | Terminated |
| D-0807-2020 | 12-18-2019 | Liothyronine (T3) 80 mcg SR cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 5 bottles | Class II | Terminated |
| D-0803-2020 | 12-18-2019 | DHEA/Pregnenol One 10.25 MG Cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0809-2020 | 12-18-2019 | Magic Bullet Supplement | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottles | Class II | Terminated |
| D-0816-2020 | 12-18-2019 | Squaric Acid 0.1% Topical Solution (Clinic) 30 mL | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0815-2020 | 12-18-2019 | Sildenafil 80 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0818-2020 | 12-18-2019 | Tadalafil 20 mg Troche | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 9 bottles | Class II | Terminated |
| D-0811-2020 | 12-18-2019 | Progesterone 200 mg Troche | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0805-2020 | 12-18-2019 | Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 jars | Class II | Terminated |
| D-0804-2020 | 12-18-2019 | Finasteride/Biotin 1 mg/50 mcg | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0817-2020 | 12-18-2019 | T3/T4 SR 9 mcg/38 mcg capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 bottles | Class II | Terminated |
| D-0812-2020 | 12-18-2019 | Progesterone 50 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0814-2020 | 12-18-2019 | Sildenafil 200 mg Troche (Clinic) | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0813-2020 | 12-18-2019 | Progesterone E4M SR 100 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 3 bottles | Class II | Terminated |
| D-0820-2020 | 12-18-2019 | Testosterone Topical Cream 4% | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 3 bottles | Class II | Terminated |
| D-0819-2020 | 12-18-2019 | Tadalafil 6 mg Capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 7 bottles | Class II | Terminated |
| D-0808-2020 | 12-18-2019 | Liothyronine (T3) 92.5 MCG | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 4 bottles | Class II | Terminated |
| D-0810-2020 | 12-18-2019 | Naltrexone 4.5 mg capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 bottles | Class II | Terminated |
| D-0806-2020 | 12-18-2019 | Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 12 jars | Class II | Terminated |
| D-0640-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 217,956 bottles | Class II | Ongoing |
| D-0641-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 98,988 bottles | Class II | Ongoing |
| D-0639-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 208,668 bottles | Class II | Ongoing |
