Urolet MB Urinary Antiseptic recall: CGMP Deviations
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate…
Why was Urolet 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?
(a) LOT # 28981501, EXP 8/17, NDC 35573-302-30; (b) LOT # 28981501, EXP 8/17, LOT # 28981601, EXP 4/18, NDC 35573-302-10
- Product
- UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate…
- Recalling firm
- Burel Pharmaceuticals Inc
- Quantity
- 11,539 bottles
- Distribution
- Nationwide
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)