Nephron Sterile Compounding Center LLC recalls 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
Recalled August 24, 2022 · FDA recall D-1346-2022 · Nephron Sterile Compounding Center
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. · FDA Class II
Units
2030 bags
Sold at
Nationwide in the USA
Description
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
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
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →