Reported Aug 24, 2022 · 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,…
Nephron Sterile Compounding Center LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nephron Sterile Compounding Center LLC · 4500 12th Street Ext · West Columbia, SC · 29172-3025
Is this the product you have?
PF-0.125% Bupivacaine HCl InjectionUSP625 mg/500 mL (1.25 mg/mL)500 mL bagpackaged in 10 x 1 IV Bag per caseRx OnlyNephron 503B Outsourcing Facility4500 12th Street ExtensionWest ColumbiaSC 29172NDC 69374-970-05
- Lot codes and dates
- Lots
BH2003AExp. 8/19/2022BH2011AExp. 11/9/2022
- Lots
- Amount recalled
- 2030 bags
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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