Drug product
EPINEPHrine added to 0.9% sodium chloride, 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 71285-8093-1.
D-0742-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8171 bags
- Official record key
drug-enforcement:D-0742-2023
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 # 37-882988, Exp 04/28/2023; 37-883194, 37-883208, Exp 04/30/2023; 37-884746, Exp 05/05/2023; 37-885215, Exp 05/08/2023; 37-885927, Exp 05/10/2023; 37-887044, 37-887051, Exp 05/15/2023; 37-887667, Exp 05/17/2023; 37-888297, 37-888298, Exp 05/21/2023; 37-890886, Exp 05/30/2023; 37-891438, Exp 06/01/2023; 37-892497, Exp 06/06/2023; 37-893159, Exp 06/08/2023; 37-893843, Exp 06/12/2023; 37-894649, Exp 06/14/2023; 37-896928, Exp 06/22/2023; 37-899304, Exp 07/03/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility