Class II
Terminated
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
This recall has been terminated (originally issued August 24, 2022).
- Recall Initiated
- August 10, 2022
- Posted
- August 24, 2022
- Recall Number
- D-1346-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2030 bags
- Firm Location
- West Columbia, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
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