Drug product
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
D-0960-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 107530 syringes
- Official record key
drug-enforcement:D-0960-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: KH1086A, Exp. 6/24/2022; KH2002B, Exp. 7/5/2022; KH2008B, Exp. 8/8/2022; KH2012A, Exp. 8/23/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility