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-0975-2023 | 07-14-2023 | oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 751 bags | Class II | Terminated |
| D-1030-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags. | Class II | Terminated |
| D-0948-2023 | 07-14-2023 | vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 3,980 bags | Class II | Terminated |
| D-0958-2023 | 07-14-2023 | EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 6,784 bags | Class II | Terminated |
| D-0972-2023 | 07-14-2023 | oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 1937 bags | Class II | Terminated |
| D-0951-2023 | 07-14-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 2,260 bags | Class II | Terminated |
| D-0998-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 420 bags | Class II | Terminated |
| D-0990-2023 | 07-14-2023 | potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 234 bags | Class II | Terminated |
| D-0995-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-0993-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 188 bags | Class II | Terminated |
| D-1039-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Terminated |
| D-0950-2023 | 07-14-2023 | vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 4824 bags | Class II | Terminated |
| D-0994-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 68 bags | Class II | Terminated |
| D-1023-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 56 bags | Class II | Terminated |
| D-0968-2023 | 07-14-2023 | vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 2,914 bags | Class II | Terminated |
| D-1024-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 308 bags | Class II | Terminated |
| D-0992-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 48 bags | Class II | Terminated |
| D-0962-2023 | 07-14-2023 | phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 1,853 bags. | Class II | Terminated |
| D-1012-2023 | 07-14-2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 33,073 bags | Class II | Terminated |
| D-0976-2023 | 07-14-2023 | oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 6037 bags | Class II | Terminated |
| D-1019-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 212 bags | Class II | Terminated |
| D-1011-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 420 bags | Class II | Terminated |
| D-0989-2023 | 07-14-2023 | potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 7469 bags | Class II | Terminated |
| D-0973-2023 | 07-14-2023 | oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 3821 bags | Class II | Terminated |
| D-0981-2023 | 07-14-2023 | heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 448 bags | Class II | Terminated |
| D-0963-2023 | 07-14-2023 | PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 9,432 bags | Class II | Terminated |
| D-0957-2023 | 07-14-2023 | EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 333 Bags | Class II | Terminated |
| D-1028-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 196 bags | Class II | Terminated |
| D-1032-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 56 bags | Class II | Terminated |
| D-1003-2023 | 07-14-2023 | oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 497 bags | Class II | Terminated |
| D-1031-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 284 | Class II | Terminated |
| D-0969-2023 | 07-14-2023 | vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 6,782 bags | Class II | Terminated |
| D-1020-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 28 bags | Class II | Terminated |
| D-1008-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 124 bags | Class II | Terminated |
| D-1035-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 172 bags | Class II | Terminated |
| D-0984-2023 | 07-14-2023 | oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 9504 bags | Class II | Terminated |
| D-1009-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 244 bags | Class II | Terminated |
| D-1027-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 132 bags | Class II | Terminated |
| D-0967-2023 | 07-14-2023 | vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 6,772 bags | Class II | Terminated |
| D-1000-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 516 bags | Class II | Terminated |
| D-1017-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 48 | Class II | Terminated |
| D-1034-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 148 bags | Class II | Terminated |
| D-0966-2023 | 07-14-2023 | vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 3,648 bags | Class II | Terminated |
| D-0991-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0425-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 24 bags | Class II | Terminated |
| D-0961-2023 | 07-14-2023 | PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 8,363 bags | Class II | Terminated |
| D-1021-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 44 bags | Class II | Terminated |
| D-0977-2023 | 07-14-2023 | heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 7,509 bags | Class II | Terminated |
| D-0965-2023 | 07-14-2023 | PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 499,304 Syringes | Class II | Terminated |
| D-1015-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 48 bags. | Class II | Terminated |
| D-1014-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-0987-2023 | 07-14-2023 | NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / I,I87 bags. | Class II | Terminated |
| D-0980-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0430-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 52 bags | Class II | Terminated |
| D-0959-2023 | 07-14-2023 | EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 4,570 bags | Class II | Terminated |
| D-1007-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 156 bags | Class II | Terminated |
| D-0964-2023 | 07-14-2023 | phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 472 bags | Class II | Terminated |
| D-1016-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-1036-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 88 bags | Class II | Terminated |
| D-0970-2023 | 07-14-2023 | vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 5,588 bags | Class II | Terminated |
| D-1018-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 192 | Class II | Terminated |
| D-0997-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 356 bags | Class II | Terminated |
| D-0960-2023 | 07-14-2023 | PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 7518 bag | Class II | Terminated |
| D-1005-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 304 bags | Class II | Terminated |
| D-1025-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 36 bags | Class II | Terminated |
| D-0988-2023 | 07-14-2023 | norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-1013-2023 | 07-14-2023 | oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 2692 bags | Class II | Terminated |
| D-0986-2023 | 07-14-2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 130,250 bags | Class II | Terminated |
| D-1029-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 144 bags. | Class II | Terminated |
| D-0983-2023 | 07-14-2023 | oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 463 bags | Class II | Terminated |
| D-1026-2023 | 07-14-2023 | TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 12 IV bags | Class II | Terminated |
| D-1033-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags. | Class II | Terminated |
| D-1040-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 72 bags | Class II | Terminated |
| D-1002-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 96 bags | Class II | Terminated |
| D-1006-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 108 bags | Class II | Terminated |
| D-0955-2023 | 07-14-2023 | vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 15,304 bags | Class II | Terminated |
| D-0996-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 296 bags | Class II | Terminated |
| D-0956-2023 | 07-14-2023 | Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 10,480 bags | Class II | Terminated |
| D-0940-2023 | 07-13-2023 | Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88. Package NDCs: 57664-228-83; 57664-228-88; 57664-228-08; 57664-228-13; 57664-228-18; 57664-229-83; 57664-229-88; 57664-229-08; 57664-229-13; 57664-229-18; 57664-230-83; 57664-230-88; 57664-230-08; 57664-230-13; 57664-230-18 | Presence of Foreign Substance: Metal embedded in a tablet. | SUN PHARMACEUTICAL INDUSTRIES INC / 7313 bottles | Class II | Terminated |
| D-0944-2023 | 07-13-2023 | Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213 | Lack of Assurance of Sterility | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy / 102 vials | Class II | Ongoing |
| D-0937-2023 | 07-11-2023 | Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 760 bottles | Class II | Ongoing |
| D-0936-2023 | 07-11-2023 | Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 65,710 vials for 1 g and 2 g strength | Class II | Ongoing |
| D-0925-2023 | 07-11-2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30. Package NDCs: 67877-476-56; 67877-476-33; 67877-476-32; 67877-476-14; 67877-476-58; 67877-476-30 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 2652 bottles | Class II | Ongoing |
| D-0935-2023 | 07-11-2023 | Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 65,710 vials for 1 g and 2 g strength | Class II | Ongoing |
| D-0929-2023 | 07-10-2023 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50; | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 209 Bags | Class II | Terminated |
| D-0915-2023 | 07-10-2023 | Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL. | CGMP Deviation: impurities exceed allowable limits. | Tenn South Distillery LLC dba Big Machine Distillery / 540 gallons | Class II | Ongoing |
| D-0914-2023 | 07-10-2023 | Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83 Package NDCs: 62756-200-83; 62756-200-18; 62756-224-83; 62756-224-88; 62756-224-08; 62756-224-18 | Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing | SUN PHARMACEUTICAL INDUSTRIES INC / 8,880 30-count bottles | Class II | Terminated |
| D-0926-2023 | 07-10-2023 | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10 | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 493 syringes | Class II | Terminated |
| D-0928-2023 | 07-10-2023 | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05 | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 500 Syringes | Class II | Terminated |
| D-0927-2023 | 07-10-2023 | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25; | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 82 Bags | Class II | Terminated |
| D-0931-2023 | 07-07-2023 | Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01. | Lack of Assurance of Sterility | SterRx, LLC / 132,299 bags | Class II | Terminated |
| D-0934-2023 | 07-07-2023 | Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01. | Lack of Assurance of Sterility | SterRx, LLC / 2,088 bags | Class II | Terminated |
| D-0932-2023 | 07-07-2023 | Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01. | Lack of Assurance of Sterility | SterRx, LLC / 125,598 bags | Class II | Terminated |
| D-0933-2023 | 07-07-2023 | Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01. | Lack of Assurance of Sterility | SterRx, LLC / 92,148 bags | Class II | Terminated |
| D-0930-2023 | 07-07-2023 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01. | Lack of Assurance of Sterility | SterRx, LLC / 137,304 bags | Class II | Terminated |
| D-0924-2023 | 07-05-2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India. Package NDCs: 62756-232-90; 62756-232-55; 62756-232-56 | Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. | SUN PHARMACEUTICAL INDUSTRIES INC / 20,884 cartons | Class III | Terminated |
| D-0913-2023 | 07-05-2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 Package NDCs: 0093-8199-28; 0093-8224-28; 0093-8229-28; 0093-8231-28 | Failed Moisture Limits: Water (moisture) content above the approved product specifications. | Teva Pharmaceuticals USA Inc / 180 bottles | Class II | Terminated |
| D-0916-2023 | 07-05-2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061858305; 0061858306 | Lack of assurance of sterility: bags have the potential to leak. | B. Braun Medical Inc. / 79,880 bags | Class II | Terminated |
| D-0917-2023 | 07-03-2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. Package NDCs: 16729-512-05; 16729-512-43 | Presence of Particulate Matter: Particulate matter identified as fiber. | Accord Healthcare, Inc. / 2348 vials | Class II | Terminated |
| D-0918-2023 | 07-03-2023 | Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. Package NDCs: 16729-275-03; 16729-275-67 | Presence of Particulate Matter: Particulate matter identified as fiber. | Accord Healthcare, Inc. / 1680 vials | Class II | Terminated |
| D-0899-2023 | 06-27-2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03 Package NDCs: 68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-03; 68180-719-09; 68180-720-09; 68180-720-03; 68180-721-03; 68180-721-09; 68180-233-01; 68180-233-02; 68180-455-02; 68180-455-01 | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. | Lupin Pharmaceuticals Inc. / 3,096 bottles | Class III | Terminated |
| D-0938-2023 | 06-27-2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60 Package NDCs: 69097-142-60 | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. / 278,538 canisters | Class I | Terminated |
