Burel Pharmaceuticals Recalls AZUPHEN MB Urinary Antiseptic Capsules
Burel Pharmaceuticals is recalling AZUPHEN MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
What this means for you
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 or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Burel Pharmaceuticals Inc is recalling 604 bottles of AZUPHEN MB Urinary Antiseptic Capsules. The product is a prescription-only medication manufactured in Richland, Mississippi, and distributed nationwide. The specific lot number is 29421501, with an expiration date of 10/17.
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.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on returning the medication or obtaining a replacement.
The recalled product
- Product
- AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 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
- 604
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 # 29421501
- EXP 10/17
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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