Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, ...
FDA Recall #D-0752-2023 — Class II — April 28, 2023
Product Description
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3326 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-884108, 37-884109, Exp 05/03/2023; 37-884957, Exp 05/07/2023; 37-885047, 37-885048, Exp 05/08/2023; 37-885919, Exp 05/10/2023; 37-889426, 37-889432, Exp 05/24/2023; 37-891933, Exp 06/05/2023; 37-894274, Exp 06/13/2023; 37-896048, 37-896049, Exp 06/20/2023; 37-897798, Exp 06/27/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated