Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

Recall Number: D-0549-2024

Firm: RemedyRepack Inc.

Classification: Class II

Status: Terminated

Report Date: 20240619

Initiation Date: 20240531

Termination Date: 20240701

Reason for Recall

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Product Description

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA