FDARecalled Jun 19, 2024 · #D-0549-2024
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
Hazard
Class II — temporary health risk
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Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. Classification: Class II Distribution: Product was distributed to one medical facility.
Product details
- 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
- Type
- Drugs
- Manufacturer
- RemedyRepack Inc.
- Model numbers
- B2906961-042524
- UPCs
- —