Reported Dec 7, 2016 · Terminated
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl…
Burel Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Burel Pharmaceuticals Inc · 199 Interstate Dr Ste N · Richland, MS · 39218-9433
Is this the product you have?
- UROPHEN MB URINARY ANTISEPTIC Tablets
- Each tablet contains
Methenamine 81.6 mgBenzoic Acid 9.0 mgPhenyl Salicylate 36 mgMethylene Blue 10.8 mgHyoscyamine Sulfate 0.12 mg100 count bottlesRx only
- Manufactured forBUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
- Lot codes and dates
LOT # 29131501EXP 9/17
- Amount recalled
- 823 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
This product could cause temporary or reversible health problems — stop using it.
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