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
Reason for recall: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Recall initiated: 20220810
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated