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Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admix

Recalled August 9, 2023 · FDA recall D-1022-2023 · Central Admixture Pharmacy Services

Hazard
Lack of assurance of sterility. Validation data for decontamination cycles is lacking. · FDA Class II
Units
80 bags
Sold at
Nationwide in the USA

Description

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

Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Manufacturer(s)
Central Admixture Pharmacy Services, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admix | RecallWatchUSA