Drug product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
D-0064-2023
Product summary
- Event
- Event 91132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,020 vials
- Official record key
drug-enforcement:D-0064-2023
Official wording
Reason: CGMP Deviations: Potential for cross contamination due to product carry over.
Code information: Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations