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FDA Drug Recalls

1,122 recalls, newest first

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

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy…

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

Central Admixture Pharmacy Services, Inc. D-1032-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High 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-1031-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central…

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

Central Admixture Pharmacy Services, Inc. D-1030-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume =…

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

Central Admixture Pharmacy Services, Inc. D-1029-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy…

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

Central Admixture Pharmacy Services, Inc. D-1028-2023

Class II · Moderate risk Terminated Jul 14, 2023

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only…

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

Central Admixture Pharmacy Services, Inc. D-1027-2023

Class II · Moderate risk Terminated Jul 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…

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

Central Admixture Pharmacy Services, Inc. D-1026-2023