Recall Enforment Report D-1129-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Central Admixture Pharmacy Services, Inc., originally initiated on 08-17-2023 for the product 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. The product was recalled due to lack of assurance of sterility:lack of validation data for sanitization cycles. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1129-202308-17-202309-06-2023Class II340 bagsEPINEPHrine, 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:Lack of validation data for sanitization cyclesTerminated
D-1118-202308-17-202309-06-2023Class II140 bagsNeonatal 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: 72196-0420-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1116-202308-17-202309-06-2023Class II200 bagsNeonatal 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: 72196-0406-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1108-202308-17-202309-06-2023Class II184CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1131-202308-17-202309-06-2023Class II554 bagsEPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), 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:Lack of validation data for sanitization cyclesTerminated
D-1135-202308-17-202309-06-2023Class II577 bagsheparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1113-202308-17-202309-06-2023Class II3519 Syringesrocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1114-202308-17-202309-06-2023Class II84 bagsNeonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1138-202308-17-202309-06-2023Class II703 bags.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: 72196-6054-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1128-202308-17-202309-06-2023Class II340 bagsPHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1124-202308-17-202309-06-2023Class II4100 syringesPHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1120-202308-17-202309-06-2023Class II132 bagsNeonatal 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: 72196-0429-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1107-202308-17-202309-06-2023Class II304 bagsCARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1130-202308-17-202309-06-2023Class II292 bags.EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1125-202308-17-202309-06-2023Class II586 bagsPHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (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:Lack of validation data for sanitization cyclesTerminated
D-1122-202308-17-202309-06-2023Class II108 bagsNeonatal 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: 72196-0422-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1136-202308-17-202309-06-2023Class II477 bagsvancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1132-202308-17-202309-06-2023Class II1,996 bags.oxyTOCIN 30 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: 72196-6039-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1134-202308-17-202309-06-2023Class II298 bagsoxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1112-202308-17-202309-06-2023Class II786 BagsCardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, 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, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1126-202308-17-202309-06-2023Class II297 bagsPHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), 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:Lack of validation data for sanitization cyclesTerminated
D-1110-202308-17-202309-06-2023Class II84 bagsCARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1123-202308-17-202309-06-2023Class II16 bagsCARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1111-202308-17-202309-06-2023Class II100 bagsCardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1117-202308-17-202309-06-2023Class II104 bagsNeonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1115-202308-17-202309-06-2023Class II40 bagsNeonatal 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: 72196-0404-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1109-202308-17-202309-06-2023Class II84 bagsCARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1133-202308-17-202309-06-2023Class II2643 bagsoxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1137-202308-17-202309-06-2023Class II235 bagsdilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1121-202308-17-202309-06-2023Class II92 bagsNeonatal 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: 72196-0431-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1119-202308-17-202309-06-2023Class II136 bagsNeonatal 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: 72196-0428-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated
D-1127-202308-17-202309-06-2023Class II292 bagsPHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1Lack of Assurance of Sterility:Lack of validation data for sanitization cyclesTerminated