Hyolev MB URINARY ANTISEPTIC Tablets recall: CGMP Deviations
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue…
Why was Hyolev 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 # 29001501, EXP 07/17
- Product
- Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue…
- Recalling firm
- Burel Pharmaceuticals Inc
- Quantity
- 2861 bottles
- Distribution
- Nationwide
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)