D-0157-2017 Class II Terminated
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
- 2,771 bottles
Product Description
URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 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 35573-300-10
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Distribution Pattern
Nationwide
Code Information
LOT # 28751601, exp 8/18