Drug product
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
D-1347-2022
Product summary
- Event
- Event 90718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,870 vials
- Official record key
drug-enforcement:D-1347-2022
Official wording
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Code information: Lot: LB2005A, Exp 3/2/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations