Drug product
Epinephrine Injection, USP, 1 mg/10 mL (100 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: 69374-925-10
D-0953-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 134415 syringes
- Official record key
drug-enforcement:D-0953-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: EN1047A, Exp. 6/7/2022; EN2002A, Exp. 7/7/2022; EN2006A, Exp. 7/19/2022; EN2011A, Exp. 9/1/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility