Drug product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
D-1251-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 134,385 syringes
- Official record key
drug-enforcement:D-1251-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: EN2007A, Exp. 7/31/2022; EN2008A, Exp. 8/18/2022; EN2013A, Exp. 9/11/2022; EN2014A, Exp. 10/2/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility