Reported Dec 7, 2016 · Terminated
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 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?
- UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets
- Each tablet containsMethenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only
- Manufactured forBUREL PHARMACEUTICALS, Richland, MS
- Lot codes and dates
(a) LOT # 28981501EXP 8/17NDC 35573-302-30(b) LOT # 28981501EXP 8/17LOT # 28981601EXP 4/18NDC 35573-302-10
- Amount recalled
- 11,539 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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