Class II Recall

Nephron Sterile Compounding Center LLC

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
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Classification
Class II
Status
Terminated
Lot
Lot: LB2005A, Exp 3/2/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.