Recalls / Class II
Class IID-0662-2023
Product
Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.
- Affected lot / code info
- Lot # 37-893850, Exp 04/28/2023; 37-894947, Exp 05/01/2023; 37-895695, Exp 05/05/2023; 37-896484, Exp 05/07/2023; 37-898314, Exp 05/14/2023; 37-898811, Exp 05/18/2023; 37-900616, Exp 05/25/2023
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
- 476 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-0662-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.