Recalls / Class II
Class IID-1347-2022
Product
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
- Affected lot / code info
- Lot: LB2005A, Exp 3/2/2023
Why it was recalled
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 33,870 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-10
- FDA classified
- 2022-08-16
- Posted by FDA
- 2022-08-24
- Terminated
- 2024-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1347-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.