Burel Pharmaceuticals Recalls UROPHEN MB Urinary Antiseptic Tablets
Burel Pharmaceuticals is recalling UROPHEN MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving potential quality failures without confirmed harm.
Plain-English summary
Burel Pharmaceuticals Inc is recalling 823 bottles of UROPHEN MB Urinary Antiseptic Tablets, 100 count bottles, NDC 35573-307-10. The affected product is identified by Lot # 29131501 and an expiration date of 9/17. The recall is due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer, which may result in assay or content uniformity failures.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on appropriate alternatives or further instructions.
The recalled product
- Product
- UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC…
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 823
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- LOT # 29131501
- EXP 9/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Burel Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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