FDAClass IIDecember 7, 2016

Indiomin MB Urinary Antiseptic recall: CGMP Deviations

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue…

Why was Indiomin MB Urinary Antiseptic recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT # 29401501, EXP 10/17

Product
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue…
Recalling firm
Burel Pharmaceuticals Inc
Quantity
795 bottles
Distribution
Nationwide
Recall date
December 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls