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FDAAugust 17, 2023drug

CARDIOPLEGIA 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: 72196-0217-1

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

What to do

FDA enforcement status: Terminated

Brands named

central admixture pharmacy servicescentralcentral admixture

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CARDIOPLEGIA 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: 72196-0217-1 — Recall Details · AllClear