Phenazopyridine Hydrochloride Tablets recalled over manufacturing violations

Recall date

October 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Burel Pharmaceuticals Inc recalls Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals…

Recall number

D-0161-2017

FDA classification

Class II

Brand / firm

Burel Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10