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-0706-2023 | 04-28-2023 | oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1. | 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. / 14362 bags | Class II | Terminated |
| D-0710-2023 | 04-28-2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1. | 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. / 104807 bags | Class II | Terminated |
| D-0682-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1. | 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. / 80 bags | Class II | Terminated |
| D-0703-2023 | 04-28-2023 | oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1. | 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. / 2624 bags | Class II | Terminated |
| D-0712-2023 | 04-28-2023 | dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6054-1. | 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. / 1230 bags | Class II | Terminated |
| D-0752-2023 | 04-28-2023 | Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781. | 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. / 3326 bags | Class II | Terminated |
| D-0742-2023 | 04-28-2023 | EPINEPHrine 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 71285-8093-1. | 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. / 8171 bags | Class II | Terminated |
| D-0671-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1. | 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. / 280 bags | Class II | Terminated |
| D-0684-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1. | 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. / 71 bags | Class II | Terminated |
| D-0743-2023 | 04-28-2023 | NORepinephrine added to dextrose 5%, 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 71285-8095-1. | 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. / 2890 bags | Class II | Terminated |
| D-0689-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/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 71285-0418-1. | 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. / 92 bags | Class II | Terminated |
| D-0699-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low 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 71285-0430-1. | 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. / 60 bags | Class II | Terminated |
| D-0650-2023 | 04-28-2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1. | 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. / 255 bags | Class II | Terminated |
| D-0695-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low 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 71285-0425-1. | 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. / 135 bags | Class II | Terminated |
| D-0716-2023 | 04-28-2023 | potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1. | 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. / 9432 bags | Class II | Terminated |
| D-0685-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1. | 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. / 138 bags | Class II | Terminated |
| D-0698-2023 | 04-28-2023 | Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1. | 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. / 328 bags | Class II | Terminated |
| D-0713-2023 | 04-28-2023 | dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1. | 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. / 3040 bags | Class II | Terminated |
| D-0733-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1. | 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. / 13953 bags | Class II | Terminated |
| D-0728-2023 | 04-28-2023 | potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1. | 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. / 2146 bags | Class II | Terminated |
| D-0729-2023 | 04-28-2023 | EPINEPHrine added to dextrose 5%, 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 71285-7018-1. | 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. / 5627 bags | Class II | Terminated |
| D-0722-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 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 71285-6076-1. | 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. / 9037 bags | Class II | Terminated |
| D-0754-2023 | 04-28-2023 | HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941. | 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. / 554 bags | Class II | Terminated |
| D-0748-2023 | 04-28-2023 | vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1. | 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. / 100 bags | Class II | Terminated |
| D-0670-2023 | 04-28-2023 | Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1. | 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. / 241 bags | Class II | Terminated |
| D-0701-2023 | 04-28-2023 | EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1. | 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. / 3338 bags | Class II | Terminated |
| D-0696-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low 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 71285-0427-1. | 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. / 259 bags | Class II | Terminated |
| D-0750-2023 | 04-28-2023 | MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291. | 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. / 653 bags | Class II | Terminated |
| D-0660-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1. | 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. / 544 bags | Class II | Terminated |
| D-0690-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0419-1. | 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. / 418 bags | Class II | Terminated |
| D-0666-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1. | 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. / 613 bags | Class II | Terminated |
| D-0679-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1. | 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. / 325 bags | Class II | Terminated |
| D-0727-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1. | 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. / 5304 bags | Class II | Terminated |
| D-0681-2023 | 04-28-2023 | Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1. | 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. / 690 syringes | Class II | Terminated |
| D-0711-2023 | 04-28-2023 | oxyTOCIN 60 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 71285-6045-1. | 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. / 1332 bags | Class II | Terminated |
| D-0719-2023 | 04-28-2023 | vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1. | 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. / 13772 bags | Class II | Terminated |
| D-0735-2023 | 04-28-2023 | phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1. | 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. / 1735 bags | Class II | Terminated |
| D-0693-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/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 71285-0422-1. | 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. / 747 bags | Class II | Terminated |
| D-0675-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1. | 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. / 226 bags | Class II | Terminated |
| D-0686-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1. | 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. / 167 bags | Class II | Terminated |
| D-0697-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low 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 71285-0428-1. | 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. / 485 bags | Class II | Terminated |
| D-0658-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1. | 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. / 267 bags | Class II | Terminated |
| D-0683-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1. | 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. / 558 bags | Class II | Terminated |
| D-0653-2023 | 04-28-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1. | 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. / 338 bags | Class II | Terminated |
| D-0755-2023 | 04-28-2023 | HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942. | 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. / 1673 bags | Class II | Terminated |
| D-0657-2023 | 04-28-2023 | Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2. | 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. / 24 bags | Class II | Terminated |
| D-0739-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1. | 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. / 1300 bags | Class II | Terminated |
| D-0720-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1. | 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. / 27780 bags | Class II | Terminated |
| D-0715-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1. | 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. / 6407 bags | Class II | Terminated |
| D-0704-2023 | 04-28-2023 | oxyTOCIN 10 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 72185-6036-1. | 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. / 2989 bags | Class II | Terminated |
| D-0663-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1. | 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. / 308 bags | Class II | Terminated |
| D-0724-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1. | 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. / 14205 bags | Class II | Terminated |
| D-0723-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1. | 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. / 7632 bags | Class II | Terminated |
| D-0678-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1. | 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. / 363 bags | Class II | Terminated |
| D-0664-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1. | 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. / 84 bags | Class II | Terminated |
| D-0648-2023 | 04-28-2023 | Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1. | 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. / 307 bags | Class II | Terminated |
| D-0744-2023 | 04-28-2023 | NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1. | 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. / 6414 bags | Class II | Terminated |
| D-0747-2023 | 04-28-2023 | vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1. | 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. / 1858 bags | Class II | Terminated |
| D-0667-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1. | 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-0746-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1. | 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. / 2992 bags | Class II | Terminated |
| D-0668-2023 | 04-28-2023 | Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1. | 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. / 12,888 bags | Class II | Terminated |
| D-0659-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1. | 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. / 350 bags | Class II | Terminated |
| D-0751-2023 | 04-28-2023 | Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771. | 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. / 3165 bags | Class II | Terminated |
| D-0737-2023 | 04-28-2023 | diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1. | 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. / 5627 bags | Class II | Terminated |
| D-0736-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1. | 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. / 8252 bags | Class II | Terminated |
| D-0688-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/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 71285-0416-1. | 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. / 139 bags | Class II | Terminated |
| D-0655-2023 | 04-28-2023 | Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1. | 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. / 12 bags | Class II | Terminated |
| D-0726-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1. | 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. / 3055 bags | Class II | Terminated |
| D-0656-2023 | 04-28-2023 | Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2. | 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. / 144 bags | Class II | Terminated |
| D-0738-2023 | 04-28-2023 | diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1. | 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. / 3999 bags | Class II | Terminated |
| D-0665-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1. | 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. / 48 bags | Class II | Terminated |
| D-0694-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0423-1. | 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. / 128 bags | Class II | Terminated |
| D-0717-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1. | 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. / 4390 bags | Class II | Terminated |
| D-0654-2023 | 04-28-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1. | 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. / 254 bags | Class II | Terminated |
| D-0673-2023 | 04-28-2023 | Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1. | 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. / 329 bags | Class II | Terminated |
| D-0672-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1. | 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. / 333 bags | Class II | Terminated |
| D-0661-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1. | 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. / 269 bags | Class II | Terminated |
| D-0649-2023 | 04-28-2023 | Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1. | 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. / 215 bags | Class II | Terminated |
| D-0705-2023 | 04-28-2023 | oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1. | 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. / 560 bags | Class II | Terminated |
| D-0725-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1. | 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. / 11338 bags | Class II | Terminated |
| D-0708-2023 | 04-28-2023 | oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1. | 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. / 3865 bags | Class II | Terminated |
| D-0732-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1. | 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. / 5207 bags | Class II | Terminated |
| D-0680-2023 | 04-28-2023 | Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1. | 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-0749-2023 | 04-28-2023 | vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1. | 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. / 4259 bags | Class II | Terminated |
| D-0731-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1. | 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. / 11117 bags | Class II | Terminated |
| D-0692-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/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 71285-0421-1. | 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. / 427 bags | Class II | Terminated |
| D-0753-2023 | 04-28-2023 | Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911. | 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. / 1516 bags | Class II | Terminated |
| D-0676-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1. | 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. / 52 bags | Class II | Terminated |
| D-0741-2023 | 04-28-2023 | tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2. | 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. / 225 syringes | Class II | Terminated |
| D-0730-2023 | 04-28-2023 | EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1. | 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. / 2542 bags | Class II | Terminated |
| D-0770-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 3032 | Class III | Terminated |
| D-0766-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 438 | Class III | Terminated |
| D-0768-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 1272 | Class III | Terminated |
| D-0769-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 1908 | Class III | Terminated |
| D-0767-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 397 | Class III | Terminated |
| D-0568-2023 | 04-26-2023 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6 Package NDCs: 60505-0823-0; 60505-0823-6 | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. | Apotex Corp. / 82,375 bottles | Class II | Completed |
| D-0840-2023 | 04-26-2023 | Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0833-2023 | 04-26-2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0809-2023 | 04-26-2023 | HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0854-2023 | 04-26-2023 | Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
