FDA Drug Recalls

774 recalls, newest first

Class II · Moderate risk Terminated Jul 17, 2023

HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc NDC 71286-2013-1 D-1057-2023

Class II · Moderate risk Terminated Jul 17, 2023

succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc NDC 71286-6011-2 D-1056-2023

Class II · Moderate risk Terminated Jul 17, 2023

HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc NDC 71286-2010-2 D-1055-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc NDC 71286-2071-3 D-1054-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1053-2023

Class II · Moderate risk Terminated Jul 17, 2023

HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1052-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1051-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1050-2023

Class II · Moderate risk Terminated Jul 17, 2023

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1049-2023

Class II · Moderate risk Terminated Jul 17, 2023

vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1048-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1047-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1046-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1045-2023

Class II · Moderate risk Terminated Jul 17, 2023

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1044-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1043-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1042-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. NDC 72196-0215-1 D-1041-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1040-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1039-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1038-2023

Class II · Moderate risk Terminated Jul 14, 2023

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1037-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1036-2023

Class II · Moderate risk Terminated Jul 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…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1035-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1034-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central…

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-1033-2023