D-1346-2022 Class II Terminated
FDA drug recall D-1346-2022 was initiated by Nephron Sterile Compounding Center LLC on Aug 10, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. The recall status is terminated (terminated Oct 11, 2024). Affected quantity: 2030 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Aug 10, 2022
- Termination Date
- Oct 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2030 bags
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1346-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026