Drug product
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
D-1346-2022
Product summary
- Event
- Event 90718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2030 bags
- Official record key
drug-enforcement:D-1346-2022
Official wording
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Code information: Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations