Recalls / Class II
Class IID-0158-2017
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 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
- Affected lot / code info
- LOT # 29131501, EXP 9/17
Why it was recalled
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recalling firm
- Firm
- Burel Pharmaceuticals Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 199 Interstate Dr Ste N, Richland, Mississippi 39218-9433
Distribution
- Quantity
- 823 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-10-24
- FDA classified
- 2016-11-29
- Posted by FDA
- 2016-12-07
- Terminated
- 2017-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0158-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.