Drug product
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
D-0065-2023
Product summary
- Event
- Event 91132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,220 vials
- Official record key
drug-enforcement:D-0065-2023
Official wording
Reason: CGMP Deviations: Potential for cross contamination due to product carry over.
Code information: Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations