Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Cent
Recalled May 31, 2023 · FDA recall D-0671-2023 · 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
280 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, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
Manufacturer(s)
Central Admixture Pharmacy Services, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →