Drug product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
D-1255-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,805 syringes
- Official record key
drug-enforcement:D-1255-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: HH2002A, Exp. 7/7/2022; HH2004A, Exp. 8/28/2022; HH2005A, Exp. 8/11/2022; HH2007A, Exp. 9/2/2022; HH2009A, Exp. 9/10/2022; HH2011A, Exp. 10/17/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility