FDA-Drug2016-12-07Class II
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
Burel Pharmaceuticals Inc
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Sold states
Nationwide
Affected count
795 bottles
Manufactured in
199 Interstate Dr Ste N, Richland, MS, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2017Don't want to check this manually?
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