FDA recall D-0160-2017

Product

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10

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-0160-2017