Recalls / Class II
Class IID-0730-2023
Product
EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
- Affected lot / code info
- Lot # 37-884156, Exp 05/03/2023; 37-885207, Exp 05/08/2023; 37-885929, Exp 05/10/2023; 37-886496, Exp 05/14/2023; 37-886817, Exp 05/15/2023; 37-887420, Exp 05/16/2023; 37-893786, Exp 06/12/2023; 37-894303, Exp 06/13/2023; 37-897893, Exp 06/27/2023; 37-900073, Exp 07/05/2023
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
- 2542 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-0730-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.