Drug 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.
D-0730-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2542 bags
- Official record key
drug-enforcement:D-0730-2023
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 # 37-884156, 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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility