Drug product
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 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: 69374-559-30
D-1257-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,570 syringes
- Official record key
drug-enforcement:D-1257-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: HN2001A, Exp. 7/23/2022; HN2003A, Exp. 8/19/2022; HN2004A, Exp. 9/9/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility