Drug product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 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: 69374-932-03
D-1270-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,520 syringes
- Official record key
drug-enforcement:D-1270-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots:NE2002A, Exp. 7/14/2022; NE2003A, Exp. 7/24/2022; NE2006A, Exp. 8/1/2022; NE2007A, Exp. 8/9/2022; NE2008A, Exp. 8/18/2022; NE2009A, Exp. 8/27/2022; NE2012D, Exp. 10/3/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility