Drug recall D-0549-2024

Class II Terminated reported Jun 19, 2024

Product

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.

Lots and codes

Lot # B2906961-042524, exp. date 02/26/2027

Recall details

Recalling firm
RemedyRepack Inc., Indiana, PA
Quantity
8 bottles
Distribution
Product was distributed to one medical facility.
Type
Voluntary: Firm initiated
Recall initiated
May 31, 2024
Terminated
July 1, 2024

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