Drug product
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 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: 69374-902-05
D-0963-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64450 syringes
- Official record key
drug-enforcement:D-0963-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: NE2001A, Exp. 6/30/2022; NE2009B, Exp. 8/27/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility