D-0155-2017 Class II Terminated
FDA drug recall D-0155-2017 was initiated by Burel Pharmaceuticals Inc on October 24, 2016 and is designated Class II. Reason for recall: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures The recall status is terminated (terminated August 14, 2017). Affected quantity: 2861 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 7, 2016
- Initiation Date
- October 24, 2016
- Termination Date
- August 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2861 bottles
Product Description
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
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Distribution Pattern
Nationwide
Code Information
LOT # 29001501, EXP 07/17