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

Recall Number: D-0161-2017

Firm: Burel Pharmaceuticals Inc

Classification: Class II

Status: Terminated

Report Date: 20161207

Initiation Date: 20161024

Termination Date: 20170814

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

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