Drug product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
D-1250-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,060 syringes
- Official record key
drug-enforcement:D-1250-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: EN2001A, Exp. 7/9/2022; EN2003A, Exp. 7/18/2022; EN2004A, Exp. 8/1/2022; EN2012A, Exp. 9/1/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility