Drug product
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
D-1344-2022
Product summary
- Event
- Event 90718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,500 vials
- Official record key
drug-enforcement:D-1344-2022
Official wording
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Code information: Lot: NE1057A, Exp. 10/23/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations