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-0049-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 492 bags | Class II | Terminated |
| D-0048-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 16585 syringes | Class II | Terminated |
| D-0118-2020 | 09-12-2019 | Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / N/A | Class II | Terminated |
| D-0112-2020 | 09-12-2019 | Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 616 vials | Class II | Terminated |
| D-0086-2020 | 09-12-2019 | PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 15260 syringes | Class II | Terminated |
| D-0084-2020 | 09-12-2019 | Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 825 syringe | Class II | Terminated |
| D-0089-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 60 bags | Class II | Terminated |
| D-0091-2020 | 09-12-2019 | Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 91 vials | Class II | Terminated |
| D-0056-2020 | 09-12-2019 | Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6620 vials | Class II | Terminated |
| D-0074-2020 | 09-12-2019 | Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 878 vials | Class II | Terminated |
| D-0115-2020 | 09-12-2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 948 vials | Class II | Terminated |
| D-0044-2020 | 09-12-2019 | L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 10014 vials | Class II | Terminated |
| D-0083-2020 | 09-12-2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4497 bags | Class II | Terminated |
| D-0045-2020 | 09-12-2019 | L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6447 vials | Class II | Terminated |
| D-0106-2020 | 09-12-2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1815 syringes | Class II | Terminated |
| D-0069-2020 | 09-12-2019 | LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4450 syringes | Class II | Terminated |
| D-0088-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 708 bags | Class II | Terminated |
| D-0105-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3820 syringes | Class II | Terminated |
| D-0114-2020 | 09-12-2019 | Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6325 vials | Class II | Terminated |
| D-0066-2020 | 09-12-2019 | Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6405 syringes | Class II | Terminated |
| D-0087-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 228 bags | Class II | Terminated |
| D-0060-2020 | 09-12-2019 | Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 928 vials | Class II | Terminated |
| D-0092-2020 | 09-12-2019 | Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 95 vials | Class II | Terminated |
| D-0078-2020 | 09-12-2019 | NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3410 syringes | Class II | Terminated |
| D-0070-2020 | 09-12-2019 | Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2615 syringes | Class II | Terminated |
| D-0099-2020 | 09-12-2019 | Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 341 vials | Class II | Terminated |
| D-0109-2020 | 09-12-2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 465 syringes | Class II | Terminated |
| D-0040-2020 | 09-12-2019 | Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2219 vials | Class II | Terminated |
| D-0055-2020 | 09-12-2019 | GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321678317 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2625 syringes | Class II | Terminated |
| D-0076-2020 | 09-12-2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 9920 syringes | Class II | Terminated |
| D-0104-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1350 syringes | Class II | Terminated |
| D-0103-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 7905 syringes | Class II | Terminated |
| D-0094-2020 | 09-12-2019 | Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 218 cartridges | Class II | Terminated |
| D-0117-2020 | 09-12-2019 | L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / N/A | Class II | Terminated |
| D-0072-2020 | 09-12-2019 | Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 497 vials | Class II | Terminated |
| D-0108-2020 | 09-12-2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 649 droptainers | Class II | Terminated |
| D-0075-2020 | 09-12-2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1290 syringes | Class II | Terminated |
| D-0046-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3895 syringes | Class II | Terminated |
| D-0107-2020 | 09-12-2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 242 droptainers | Class II | Terminated |
| D-0141-2020 | 09-12-2019 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 | CGMP Deviations: Received notice from supplier that there is potential glass contamination. | Spectrum Laboratory Products / 29.1 grams | Class II | Terminated |
| D-0073-2020 | 09-12-2019 | Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1189 vials | Class II | Terminated |
| D-0077-2020 | 09-12-2019 | NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 7685 syringes | Class II | Terminated |
| D-0101-2020 | 09-12-2019 | Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 540 syringes | Class II | Terminated |
| D-0062-2020 | 09-12-2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 345 vials | Class II | Terminated |
| D-0061-2020 | 09-12-2019 | Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1528 | Class II | Terminated |
| D-0067-2020 | 09-12-2019 | LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4105 syringes | Class II | Terminated |
| D-0042-2020 | 09-12-2019 | Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6568 vials | Class II | Terminated |
| D-0059-2020 | 09-12-2019 | Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2263 vials | Class II | Terminated |
| D-0079-2020 | 09-12-2019 | Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4390 vials | Class II | Terminated |
| D-0085-2020 | 09-12-2019 | PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3150 vials | Class II | Terminated |
| D-0050-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 934 bags | Class II | Terminated |
| D-0064-2020 | 09-12-2019 | Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1044 syringes | Class II | Terminated |
| D-0054-2020 | 09-12-2019 | GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 10630 syringes | Class II | Terminated |
| D-0093-2020 | 09-12-2019 | Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 258 vials | Class II | Terminated |
| D-0047-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 12445 syringes | Class II | Terminated |
| D-0081-2020 | 09-12-2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1464 bags | Class II | Terminated |
| D-0102-2020 | 09-12-2019 | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 150 vials | Class II | Terminated |
| D-0058-2020 | 09-12-2019 | Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2219 vials | Class II | Terminated |
| D-0100-2020 | 09-12-2019 | Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 120 vials | Class II | Terminated |
| D-0052-2020 | 09-12-2019 | Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1980 vials | Class II | Terminated |
| D-0096-2020 | 09-12-2019 | Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 246 vials | Class II | Terminated |
| D-0097-2020 | 09-12-2019 | Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 152 cartridges | Class II | Terminated |
| D-0113-2020 | 09-12-2019 | Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 470 vials | Class II | Terminated |
| D-0095-2020 | 09-12-2019 | Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 647 vials | Class II | Terminated |
| D-0051-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1882 bags | Class II | Terminated |
| D-0098-2020 | 09-12-2019 | Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 64 vials | Class II | Terminated |
| D-0063-2020 | 09-12-2019 | Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 345 vials | Class II | Terminated |
| D-0041-2020 | 09-12-2019 | Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 602 vials | Class II | Terminated |
| D-0090-2020 | 09-12-2019 | Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 317 vials | Class II | Terminated |
| D-0043-2020 | 09-12-2019 | Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 162 vials | Class II | Terminated |
| D-0110-2020 | 09-12-2019 | Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6747 vials | Class II | Terminated |
| D-0071-2020 | 09-12-2019 | LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2255 syringes | Class II | Terminated |
| D-0039-2020 | 09-12-2019 | Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 77 vials | Class II | Terminated |
| D-0053-2020 | 09-12-2019 | Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 402 vials | Class II | Terminated |
| D-0111-2020 | 09-12-2019 | Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 508 vials | Class II | Terminated |
| D-0002-2020 | 09-12-2019 | Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 Package NDCs: 0071-0237-24 | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. | Pfizer Inc. / 7,686 100-count bottles | Class III | Terminated |
| D-0001-2020 | 09-12-2019 | ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. | Pfizer Inc. / 7,824 100-count bottles | Class III | Terminated |
| D-1863-2019 | 09-09-2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59 | Failed Impurities/Degradation Specificattion | West-Ward Columbus Inc / 32,347 bottles | Class II | Terminated |
| D-1876-2019 | 09-06-2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42. Package NDCs: 0173-0881-01; 0173-0881-61; 0173-0892-01; 0173-0892-42; 0173-0892-61; 0173-0892-63; 0173-0904-42 | Temperature Abuse; Product stored and shipped outside of labeled storage requirements. | Cardinal Health dba Specialty Pharmaceutical Services / 38 syringes | Class II | Terminated |
| D-0131-2020 | 09-06-2019 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30 Package NDCs: 52544-691-30; 52544-691-19; 52544-691-10; 52544-692-30; 52544-692-19; 52544-692-10; 52544-693-30; 52544-693-19; 52544-693-10; 52544-694-30; 52544-694-19; 52544-694-10; 52544-695-30; 52544-695-19; 52544-695-10 | GMP Deviation: lot not intended for commercial distribution. | Teva Pharmaceuticals USA / 5,849 bottles | Class III | Terminated |
| D-1852-2019 | 09-06-2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 Package NDCs: 0409-3977-01; 0409-3977-03; 0409-1093-14; 0409-1093-04 | Lack of Assurance of Sterility | Pfizer Inc. / 185,700 vials | Class II | Terminated |
| D-0125-2020 | 09-06-2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707 | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin. | Darmerica, LLC / 1.8 kilograms | Class I | Terminated |
| D-1848-2019 | 09-06-2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35 | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Mylan Pharmaceuticals Inc. / 13,157 5 mL bottles | Class III | Terminated |
| D-1862-2019 | 09-06-2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01. Package NDCs: 13668-453-30; 13668-453-01; 13668-462-30; 13668-462-01 | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing. | Torrent Pharma Inc. / 2472 bottles | Class II | Terminated |
| D-0145-2020 | 09-04-2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90 | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Jubilant Cadista Pharmaceuticals, Inc. / 63,216 bottles | Class II | Terminated |
| D-1854-2019 | 09-03-2019 | 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles | Lack of Processing Controls: | Compounded Solutions in Pharmacy / a) 6x5ml b) 4x10 c) 1x15 ml bottles, | Class II | Terminated |
| D-1853-2019 | 09-03-2019 | 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. | Lack of Processing Controls: | Compounded Solutions in Pharmacy / 3x3 ml dropper bottles | Class II | Terminated |
| D-1855-2019 | 09-03-2019 | 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles | Lack of Processing Controls: | Compounded Solutions in Pharmacy / a) 4x5 ml, b) 1x10 ml bottles | Class II | Terminated |
| D-0606-2020 | 09-03-2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0587-2020 | 09-03-2019 | Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0586-2020 | 09-03-2019 | Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0595-2020 | 09-03-2019 | Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0599-2020 | 09-03-2019 | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0584-2020 | 09-03-2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0601-2020 | 09-03-2019 | Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0588-2020 | 09-03-2019 | Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0580-2020 | 09-03-2019 | Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0607-2020 | 09-03-2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0602-2020 | 09-03-2019 | Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0605-2020 | 09-03-2019 | Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
