Drug product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
D-1267-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,385 syringes
- Official record key
drug-enforcement:D-1267-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: MS2001A, Exp. 7/2/2022; MS2006A, Exp. 8/9/2022; MS2009A, Exp. 8/25/2022; MS2011A, Exp. 9/3/2022; MS2017A, Exp. 10/2/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility