Azuphen MB Urinary Antiseptic Capsules recall: CGMP Deviations
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg…
Why was Azuphen MB Urinary Antiseptic Capsules 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 # 29421501, EXP 10/17
- Product
- AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg…
- Recalling firm
- Burel Pharmaceuticals Inc
- Quantity
- 604 bottles
- Distribution
- Nationwide
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)