Drug 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
D-0549-2024
Product summary
- Event
- Event 94738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 bottles
- Official record key
drug-enforcement:D-0549-2024
Official wording
Reason: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Code information: Lot # B2906961-042524, exp. date 02/26/2027
Distribution pattern: Product was distributed to one medical facility.
Derived failure modes
-
Unknown
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.