Recalls / Class II
Class IID-0752-2023
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, N/A, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 3326 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-04-28
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2025-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0752-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.