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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0830-2020 | 01-27-2020 | Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01 | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 22,868 bottles | Class II | Terminated |
| D-0838-2020 | 01-24-2020 | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09 | Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. | Macleods Pharma Usa Inc / 4694 30x60-count bottles | Class III | Terminated |
| D-0828-2020 | 01-24-2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90. Package NDCs: 67877-445-30; 67877-445-90; 67877-445-05; 67877-445-10; 67877-446-30; 67877-446-90; 67877-446-05; 67877-446-10; 67877-446-33; 67877-446-84; 67877-446-74; 67877-446-38; 67877-447-30; 67877-447-90; 67877-447-05; 67877-447-10 | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. | Ascend Laboratories LLC / 192 Bottles | Class II | Terminated |
| D-1050-2020 | 01-24-2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. | Breckenridge Pharmaceutical, Inc / 11,250 bottles | Class II | Terminated |
| D-1051-2020 | 01-24-2020 | Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. | Breckenridge Pharmaceutical, Inc / 11, 250 bottles | Class II | Terminated |
| D-0827-2020 | 01-22-2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30. Package NDCs: 67877-578-14; 67877-578-30; 67877-578-01; 67877-578-05; 67877-576-14; 67877-576-30; 67877-576-01; 67877-576-05; 67877-577-14; 67877-577-30; 67877-577-01; 67877-577-05; 67877-643-14; 67877-643-30; 67877-643-01; 67877-643-05; 67877-644-14; 67877-644-30; 67877-644-01; 67877-644-05; 67877-436-14; 67877-436-30; 67877-436-01; 67877-436-05; 67877-437-14; 67877-437-30; 67877-437-01; 67877-437-05; 67877-438-14; 67877-438-30; 67877-438-01; 67877-438-05 | Failed Dissolution Specifications: low out of specification results for dissolution testing. | Ascend Laboratories LLC / 4728 bottles | Class III | Terminated |
| D-0823-2020 | 01-20-2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10 Package NDCs: 33342-110-07; 33342-110-10; 33342-110-15; 33342-110-12; 33342-110-39; 33342-110-44; 33342-111-07; 33342-111-10; 33342-111-15; 33342-111-12; 33342-111-39; 33342-111-44 | Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product | Macleods Pharma Usa Inc / 10680 units | Class III | Terminated |
| D-0822-2020 | 01-16-2020 | Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11 | Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing). | Shandex Personal Care Manufacturing Inc. / 20448 cartons | Class II | Terminated |
| D-0940-2020 | 01-15-2020 | AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0975-2020 | 01-15-2020 | MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0955-2020 | 01-15-2020 | Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0934-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0985-2020 | 01-15-2020 | Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0958-2020 | 01-15-2020 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0970-2020 | 01-15-2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0948-2020 | 01-15-2020 | Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0994-2020 | 01-15-2020 | Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0978-2020 | 01-15-2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0959-2020 | 01-15-2020 | Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0976-2020 | 01-15-2020 | Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0982-2020 | 01-15-2020 | Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0946-2020 | 01-15-2020 | Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0943-2020 | 01-15-2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0965-2020 | 01-15-2020 | Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0991-2020 | 01-15-2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0935-2020 | 01-15-2020 | Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0956-2020 | 01-15-2020 | Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0966-2020 | 01-15-2020 | Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0947-2020 | 01-15-2020 | Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0989-2020 | 01-15-2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0988-2020 | 01-15-2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0974-2020 | 01-15-2020 | MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0933-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0952-2020 | 01-15-2020 | Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0977-2020 | 01-15-2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0992-2020 | 01-15-2020 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0979-2020 | 01-15-2020 | Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0953-2020 | 01-15-2020 | Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0962-2020 | 01-15-2020 | Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0941-2020 | 01-15-2020 | B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0973-2020 | 01-15-2020 | MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0942-2020 | 01-15-2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0984-2020 | 01-15-2020 | Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0967-2020 | 01-15-2020 | Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0987-2020 | 01-15-2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0950-2020 | 01-15-2020 | Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0993-2020 | 01-15-2020 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0932-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0969-2020 | 01-15-2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0624-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0937-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0949-2020 | 01-15-2020 | Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0961-2020 | 01-15-2020 | Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0960-2020 | 01-15-2020 | Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0936-2020 | 01-15-2020 | Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0990-2020 | 01-15-2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0938-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0983-2020 | 01-15-2020 | Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0968-2020 | 01-15-2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0623-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0980-2020 | 01-15-2020 | Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0964-2020 | 01-15-2020 | Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class III | Terminated |
| D-0971-2020 | 01-15-2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0957-2020 | 01-15-2020 | Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0339-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0981-2020 | 01-15-2020 | Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0954-2020 | 01-15-2020 | Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0972-2020 | 01-15-2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0944-2020 | 01-15-2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0945-2020 | 01-15-2020 | Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0963-2020 | 01-15-2020 | Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0986-2020 | 01-15-2020 | Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0939-2020 | 01-15-2020 | AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0951-2020 | 01-15-2020 | Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0017-2021 | 01-15-2020 | Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30 | CGMP Deviations: Presence of NDMA impurity detected in product. | Direct Rx / 26 bottles | Class II | Terminated |
| D-0016-2021 | 01-15-2020 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 | CGMP Deviations: Presence of NDMA impurity detected in product. | Direct Rx / a) 54 bottles; b) 26 bottles | Class II | Terminated |
| D-0824-2020 | 01-14-2020 | Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16 Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | Subpotent: Out of specification for assay at the 12-month time point. | Pharmaceutical Associates Inc / 6288 16 oz bottles | Class II | Terminated |
| D-0825-2020 | 01-14-2020 | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram | CGMP Deviations: Presence of NDMA impurity detected in product. | Spectrum Laboratory Products / N/A | Class II | Terminated |
| D-0788-2020 | 01-14-2020 | Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. | Sun Pharmaceutical Industries, Inc. / | Class II | Terminated |
| D-0787-2020 | 01-14-2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. | Sun Pharmaceutical Industries, Inc. / | Class II | Terminated |
| D-0801-2020 | 01-14-2020 | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01. Package NDCs: 0143-9850-01; 0143-9851-01 | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol. | Hikma Pharmaceuticals USA Inc. / 4840 vials | Class III | Terminated |
| D-0799-2020 | 01-10-2020 | NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40. Package NDCs: 69488-001-40 | Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2). | Advanced Accelerator Applications USA, Inc. / 4295 Kits | Class II | Terminated |
| D-0826-2020 | 01-10-2020 | ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. | PD-Rx Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0780-2020 | 01-10-2020 | Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601 | Subpotent | Letco Medical LLC / a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars | Class II | Terminated |
| D-0790-2020 | 01-10-2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet) | CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. | Lupin Pharmaceuticals Inc. / 34,080 boxes (3 wallets per carton, 80 cartons per box) | Class III | Terminated |
| D-0792-2020 | 01-07-2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. / 16,944 bottles of 30 capsules | Class II | Terminated |
| D-0791-2020 | 01-07-2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. / 31,736 bottles of 60 capsules | Class II | Terminated |
| D-0661-2020 | 01-07-2020 | Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13. | Failed Impurities/Degradation Specifications: High out of specification results for related compounds. | AVKARE Inc. / 3,989 cartons | Class II | Terminated |
| D-0796-2020 | 01-07-2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1) | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc / 221,710 tablets | Class II | Terminated |
| D-0797-2020 | 01-07-2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0) | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc / 39,172 tablets | Class II | Terminated |
| D-0649-2020 | 01-07-2020 | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Appco Pharma LLC / 624 bottes | Class II | Terminated |
| D-0782-2020 | 01-07-2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. | Microbial contamination of non-sterile product. | Sigan Industries Inc. / 11,004 bottles | Class III | Terminated |
| D-0648-2020 | 01-07-2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Appco Pharma LLC / 1,632 bottes | Class II | Terminated |
| D-0793-2020 | 01-06-2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60 | CGMP Deviations: Presence of NDMA impurity detected in product. | H J Harkins Company Inc dba Pharma Pac / 7,212 tablets | Class II | Terminated |
| D-0867-2020 | 12-27-2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00 | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples. | RemedyRepack Inc. / 75 1 ml vials | Class I | Terminated |
| D-0638-2020 | 12-26-2019 | Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11 | Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack. | Lupin Pharmaceuticals Inc. / 41,863 cartons/3 wallets per carton | Class II | Terminated |
| D-0659-2020 | 12-26-2019 | Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ Package NDCs: 62756-520-83; 62756-520-88; 62756-520-08; 62756-520-18; 62756-520-69; 62756-520-93; 62756-520-01; 62756-521-83; 62756-521-88; 62756-521-08; 62756-521-18; 62756-521-69; 62756-521-93; 62756-521-01; 62756-522-83; 62756-522-88; 62756-522-08; 62756-522-18; 62756-522-69; 62756-522-93; 62756-522-01 | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. / 384/100 count bottles | Class II | Terminated |
| D-0660-2020 | 12-26-2019 | Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. / 207,585 blisters | Class II | Terminated |
| D-1388-2020 | 12-26-2019 | Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12 | Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample | Akorn, Inc. / 33,343 bottles | Class III | Terminated |
| D-0646-2020 | 12-26-2019 | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AAA Pharmaceutical, Inc. / 31,536 (130-count bottles) | Class II | Terminated |
| D-0645-2020 | 12-26-2019 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AAA Pharmaceutical, Inc. / 34,272 (24-count bottles) | Class II | Terminated |
| D-0996-2020 | 12-23-2019 | Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03 | Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet. | GSK Consumer Health, Inc / 431,614 cartons | Class II | Terminated |
| D-0795-2020 | 12-20-2019 | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131 | CGMP Deviations: Presence of NDMA impurity detected in product. | Denton Pharma, Inc. / 467 bottles | Class II | Terminated |
