Drug product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 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: 69374-511-01
D-1261-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,905 syringes
- Official record key
drug-enforcement:D-1261-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: KH2009A, Exp. 8/16/2022; KH2011A, Exp. 8/24/2022; KH2013A, Exp. 8/28/2022; KH2014A, Exp. 9/9/2022; KH2018A, Exp. 10/7/2022; KH2020A, Exp. 10/18/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility