Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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