FDAFDA · Food and drugs·Recall number D-1346-2022
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
Published August 24, 2022 · Recall initiated: August 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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