FDA recall D-0155-2017

Product

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-10-24

Report date

2016-12-07

Termination date

2017-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richland, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2017