Urophen MB Urinary Antiseptic Tablets recall: CGMP Deviations
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8…
Why was Urophen MB Urinary Antiseptic Tablets 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 # 29131501, EXP 9/17
- Product
- UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8…
- Recalling firm
- Burel Pharmaceuticals Inc
- Quantity
- 823 bottles
- Distribution
- Nationwide
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)