Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
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 labeled as 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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.