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-0592-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 236,610 vials | Class II | Terminated |
| D-0587-2023 | 05-15-2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 80,850 vials | Class II | Terminated |
| D-0609-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 550,160 vials | Class II | Terminated |
| D-0585-2023 | 05-15-2023 | Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 53,220 vials | Class II | Terminated |
| D-0603-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 23,187 bottles | Class II | Terminated |
| D-0629-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 169,520 Vials | Class II | Terminated |
| D-0586-2023 | 05-15-2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 59,530 vials | Class II | Terminated |
| D-0601-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 119,340 vials | Class II | Terminated |
| D-0630-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 936,680 vials | Class II | Terminated |
| D-0610-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 964,420 vials | Class II | Terminated |
| D-0588-2023 | 05-15-2023 | Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 220,340 vials | Class II | Terminated |
| D-0631-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 393,930 vials | Class II | Terminated |
| D-0620-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 7,940 bottles | Class II | Terminated |
| D-0602-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 591,160 vials | Class II | Terminated |
| D-0623-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 110,660 vials | Class II | Terminated |
| D-0591-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 419,680 vials | Class II | Terminated |
| D-0628-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 138,610 vials | Class II | Terminated |
| D-0582-2023 | 05-15-2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 89,690 vials | Class II | Terminated |
| D-0608-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 51,280 vials | Class II | Terminated |
| D-0604-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 101,550 vials | Class II | Terminated |
| D-0584-2023 | 05-15-2023 | Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 8,925 bottles | Class II | Terminated |
| D-0618-2023 | 05-15-2023 | Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 739,750 vials | Class II | Terminated |
| D-0619-2023 | 05-15-2023 | Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 243,825 vials | Class II | Terminated |
| D-0600-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 91,860 vials | Class II | Terminated |
| D-0607-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 41,320 vials | Class II | Terminated |
| D-0612-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 65,950 vials | Class II | Terminated |
| D-0611-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,250 vials | Class II | Terminated |
| D-0595-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 357,550 vials | Class II | Terminated |
| D-0625-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 249,080 vials | Class II | Terminated |
| D-0615-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 9,040 bottles | Class II | Terminated |
| D-0626-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 112,640 vials | Class II | Terminated |
| D-0583-2023 | 05-15-2023 | Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 45,160 vials | Class II | Terminated |
| D-0605-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 124,010 vials | Class II | Terminated |
| D-0606-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 107,320 vials | Class II | Terminated |
| D-0581-2023 | 05-15-2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 17,350 vials | Class II | Terminated |
| D-0599-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 6,127 bottles | Class II | Terminated |
| D-0598-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 11,555 bottles | Class II | Terminated |
| D-0621-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,288,510 vials | Class II | Terminated |
| D-0597-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,001,110 vials | Class II | Terminated |
| D-0580-2023 | 05-15-2023 | Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 70,040 vials | Class II | Terminated |
| D-0590-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 59,040 vials | Class II | Terminated |
| D-0613-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 73,475 vials | Class II | Terminated |
| D-0622-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 204,860 vials | Class II | Terminated |
| D-0614-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 41,500 vials | Class II | Terminated |
| D-0624-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 893,950 vials | Class II | Terminated |
| D-0627-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 223,590 vials | Class II | Terminated |
| D-0596-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 58,770 vials | Class II | Terminated |
| D-0589-2023 | 05-15-2023 | Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 7,214 bottles | Class II | Terminated |
| D-0594-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 35,087 bottles | Class II | Terminated |
| D-0616-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,125 vials | Class II | Terminated |
| D-0865-2023 | 05-12-2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1 | Mislabeling: preservative free product labeled as preserved. | Empower Clinic Services LLC dba Empower Pharmacy / 504 vials | Class II | Completed |
| D-0574-2023 | 05-11-2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724. Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. | Hikma Pharmaceuticals USA Inc. / 1,352,475 vials | Class II | Terminated |
| D-0771-2023 | 05-11-2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64. | Sub-potent Drug | Revive Rx LLC dba Revive Rx Pharmacy / 45 Vials | Class II | Ongoing |
| D-0776-2023 | 05-09-2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 3,232 syringes | Class II | Ongoing |
| D-0579-2023 | 05-09-2023 | Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20, Package NDCs: 0264-9567-10; 0264-9577-10; 0264-9587-20 | Subpotent: Low anti-factor IIa Potency. | B. Braun Medical Inc / 1,380 | Class II | Terminated |
| D-0761-2023 | 05-09-2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications; during stability testing | SUN PHARMACEUTICAL INDUSTRIES INC / 5,344 Bottles | Class II | Terminated |
| D-0756-2023 | 05-08-2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01. | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1. | Amneal Pharmaceuticals of New York, LLC / 69,239 vials | Class III | Terminated |
| D-0775-2023 | 05-03-2023 | Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC / 13,968 bottles | Class II | Ongoing |
| D-0774-2023 | 05-03-2023 | Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02 | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC / 4,812 units | Class II | Ongoing |
| D-0772-2023 | 05-03-2023 | Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC / 86,616 4 OZ bottles | Class II | Ongoing |
| D-0773-2023 | 05-03-2023 | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240. | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC / 54,222 bottles | Class II | Ongoing |
| D-0869-2023 | 05-03-2023 | Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83. Package NDCs: 62756-459-83; 62756-459-64; 62756-460-83; 62756-460-64 | CGMP Deviations | SUN PHARMACEUTICAL INDUSTRIES INC / 12,336 bottles | Class II | Terminated |
| D-0645-2023 | 05-02-2023 | VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 491 bags | Class II | Ongoing |
| D-0640-2023 | 05-02-2023 | VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 1622 bags | Class II | Ongoing |
| D-0632-2023 | 05-02-2023 | PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10 | Lack of Assurance of Sterility | Apollo Care, LLC / 2265 syringes | Class II | Ongoing |
| D-0637-2023 | 05-02-2023 | Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 1617 bags | Class II | Ongoing |
| D-0633-2023 | 05-02-2023 | Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05 | Lack of Assurance of Sterility | Apollo Care, LLC / 90 syringes | Class II | Ongoing |
| D-0634-2023 | 05-02-2023 | FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 790 syringes | Class II | Ongoing |
| D-0636-2023 | 05-02-2023 | VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50 | Lack of Assurance of Sterility | Apollo Care, LLC / 2040 bags | Class II | Ongoing |
| D-0642-2023 | 05-02-2023 | VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50 | Lack of Assurance of Sterility | Apollo Care, LLC / 413 bags | Class II | Ongoing |
| D-0638-2023 | 05-02-2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 1113 bags | Class II | Ongoing |
| D-0641-2023 | 05-02-2023 | VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50 | Lack of Assurance of Sterility | Apollo Care, LLC / 240 bags | Class II | Ongoing |
| D-0639-2023 | 05-02-2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 1113 bags | Class II | Ongoing |
| D-0635-2023 | 05-02-2023 | Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05 | Lack of Assurance of Sterility | Apollo Care, LLC / 2040 syringes | Class II | Ongoing |
| D-0647-2023 | 05-02-2023 | VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 646 bags | Class II | Ongoing |
| D-0644-2023 | 05-02-2023 | Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 682 bags | Class II | Ongoing |
| D-0646-2023 | 05-02-2023 | FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 308 bags | Class II | Ongoing |
| D-0643-2023 | 05-02-2023 | VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50 | Lack of Assurance of Sterility | Apollo Care, LLC / 54 bags | Class II | Ongoing |
| D-0576-2023 | 05-01-2023 | LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | RemedyRepack Inc. / 9,038 vials | Class II | Terminated |
| D-0939-2023 | 05-01-2023 | Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20. Package NDCs: 72657-112-90; 72657-112-20; 72657-113-88; 72657-113-20; 72657-132-01 | Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg. | Glenmark Therapeutics, Inc. / 19,968 bottles | Class II | Terminated |
| D-0578-2023 | 05-01-2023 | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | RemedyRepack Inc. / 29 x 30-count card, 1 x 100 UD box | Class II | Ongoing |
| D-0577-2023 | 05-01-2023 | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10; | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | RemedyRepack Inc. / 12 5mL bottles | Class II | Ongoing |
| D-0662-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 476 bags | Class II | Terminated |
| D-0707-2023 | 04-28-2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 21871 bags | Class II | Terminated |
| D-0734-2023 | 04-28-2023 | NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 6341 bags | Class II | Terminated |
| D-0677-2023 | 04-28-2023 | Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 79 bags | Class II | Terminated |
| D-0718-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 3075 bags | Class II | Terminated |
| D-0745-2023 | 04-28-2023 | NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 4994 bags | Class II | Terminated |
| D-0652-2023 | 04-28-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 140 bags | Class II | Terminated |
| D-0669-2023 | 04-28-2023 | Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 182 bags | Class II | Terminated |
| D-0651-2023 | 04-28-2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 151 bags | Class II | Terminated |
| D-0691-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0420-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 877 bags | Class II | Terminated |
| D-0740-2023 | 04-28-2023 | oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 2186 bags | Class II | Terminated |
| D-0700-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 175 bags | Class II | Terminated |
| D-0714-2023 | 04-28-2023 | norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 2041 bags | Class II | Terminated |
| D-0721-2023 | 04-28-2023 | vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 10282 bags | Class II | Terminated |
| D-0702-2023 | 04-28-2023 | oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 7595 bags | Class II | Terminated |
| D-0674-2023 | 04-28-2023 | Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 208 bags | Class II | Terminated |
| D-0687-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 258 bags | Class II | Terminated |
| D-0709-2023 | 04-28-2023 | oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 5544 bags | Class II | Terminated |
