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
Reported: August 24, 2022 Initiated: August 10, 2022 #D-1346-2022
Product Description
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 for Recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 2030 bags
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 2030 bags.
Why was this product recalled? ▼
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1346-2022.
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