Reported Dec 7, 2016 · Terminated
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg,…
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?
- Hyolev MB URINARY ANTISEPTIC Tablets, Each
- tablet for oral administration contains
Hyoscyamine Sulfate 0.12 mgMethenamine 81 mgMethylene Blue 10.8 mgPhenyl Salicylate 32.4 mgSodium Phosphate Monobasic 40.8 mg90 count bottlesRx only
- Manufactured forBUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
- Lot codes and dates
LOT # 29001501EXP 07/17
- Amount recalled
- 2861 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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