FDA recall D-0156-2017

Product

UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS

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-0156-2017