Recalls / Class II
Class IID-0064-2023
Product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
- Affected lot / code info
- Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
Why it was recalled
CGMP Deviations: Potential for cross contamination due to product carry over.
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 34,020 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-11-10
- FDA classified
- 2022-11-17
- Posted by FDA
- 2022-11-23
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0064-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.