Drug product
EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7018-1.
D-0729-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5627 bags
- Official record key
drug-enforcement:D-0729-2023
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 # 37-883218, Exp 04/30/2023; 37-885235, Exp 05/08/2023; 37-885923, Exp 05/10/2023; 37-889050, Exp 05/23/2023; 37-890053, 37-890054, Exp 05/28/2023; 37-891439, 37-891441, Exp 06/01/2023; 37-892500, Exp 06/06/2023; 37-894308, Exp 06/13/2023; 37-896125, Exp 06/20/2023; 37-896926, Exp 06/22/2023; 37-900396, Exp 07/06/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility