Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Ce
Recalled May 31, 2023 · FDA recall D-0659-2023 · Central Admixture Pharmacy Services
Hazard
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. · FDA Class II
Units
350 bags
Sold at
Nationwide in the USA.
Description
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Product
Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.
Manufacturer(s)
Central Admixture Pharmacy Services, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →