FDA-Drug2016-12-07Class II
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Burel Pharmaceuticals Inc
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Sold states
Nationwide
Affected count
35,149 bottles
Manufactured in
199 Interstate Dr Ste N, Richland, MS, United States
Products
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2017Don't want to check this manually?
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