Recalls / Class II
Class IID-0155-2017
Product
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
- Affected lot / code info
- LOT # 29001501, EXP 07/17
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
- 2861 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-0155-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.