Drug product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
D-0952-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35850 syringes
- Official record key
drug-enforcement:D-0952-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: EN2005A, Exp. 7/25/2022; EN2009A, Exp. 8/20/2022; EN2010A, Exp. 9/13/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility