Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., ...
FDA Recall #D-0549-2024 — Class II — May 31, 2024
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
Reason for Recall
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recalling Firm
RemedyRepack Inc. — Indiana, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8 bottles
Distribution
Product was distributed to one medical facility.
Code Information
Lot # B2906961-042524, exp. date 02/26/2027
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated