Class II Recall

Nephron Sterile Compounding Center LLC

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
Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Classification
Class II
Status
Terminated
Lot
Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Nephron Sterile Compounding Center LLC — Class II Recall | MedicineWatch US