Drug product
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.
D-0752-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3326 bags
- Official record key
drug-enforcement:D-0752-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility