Reported Dec 7, 2016 · Terminated
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium…
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?
- Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules
- Each capsule contains
Methenamine 120 mgMonobasic Sodium Phosphate 40.8 mgMethylene Blue10 mgHyoscyamine Sulfate0.12 mg100 countRx only
- Manufactured forBUREL PHARMACEUTICALS, NDC 35573-315-10
- Lot codes and dates
LOT # 29401501EXP 10/17
- Amount recalled
- 795 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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