FDA-Drug2022-08-24Class II
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
Nephron Sterile Compounding Center LLC
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Sold states
Nationwide in the USA
Affected count
2030 bags
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1346-2022Don't want to check this manually?
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