Burel Pharmaceuticals Inc recalls Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals,
Recalled December 7, 2016 · FDA recall D-0161-2017 · Burel Pharmaceuticals
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures · FDA Class II
Units
17,788 bottles
Sold at
Nationwide
Description
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Manufacturer(s)
Burel Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →