Burel Pharmaceuticals Recalls Uramit MB Urinary Antiseptic Capsules
Burel Pharmaceuticals is recalling Uramit MB Urinary Antiseptic Capsules 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of content uniformity failure without reported adverse events, fitting the criteria for a moderate severity score.
Plain-English summary
Burel Pharmaceuticals Inc is recalling 2,771 bottles of Uramit MB Urinary Antiseptic Capsules. The affected product is identified by Lot # 28751601 and has an expiration date of 8/18. The capsules are prescription-only and were distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer. These issues may result in assay or content uniformity failures, meaning the medication may not contain the correct amount of active ingredients or may not be consistent throughout the bottle.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as FDA Class II.
The recalled product
- Product
- URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS…
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 2,771
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 # 28751601
- exp 8/18
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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