D-0549-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2024
- Initiation Date
- May 31, 2024
- Termination Date
- July 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 bottles
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.
Distribution Pattern
Product was distributed to one medical facility.
Code Information
Lot # B2906961-042524, exp. date 02/26/2027