D-0159-2017 Class II Terminated
FDA drug recall D-0159-2017 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: 604 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
- 604 bottles
Product Description
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Distribution Pattern
Nationwide
Code Information
LOT # 29421501, EXP 10/17