Drug product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 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: 69374-985-05
D-1264-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,310 syringes
- Official record key
drug-enforcement:D-1264-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: LI2004A, Exp. 8/6/2022; LI2005A, Exp. 8/31/2022; LI2006A, Exp. 9.21.2022; LI2008A, Exp. 10/11/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility