Drug product
EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
D-0701-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3338 bags
- Official record key
drug-enforcement:D-0701-2023
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 # 37-884448, Exp 05/04/2023; 37-887386, Exp 05/16/2023; 37-888271, Exp 05/21/2023; 37-891189, Exp 05/31/2023; 37-893456, Exp 06/11/2023; 37-894656, Exp 06/14/2023; 37-898333, Exp 06/28/2023; 37-898559, Exp 06/29/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility