Recalls / Class II
Class IID-0156-2017
Product
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
- Affected lot / code info
- (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
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
- 11,539 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-0156-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.