Burel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling 795 bottles of Indiomin MB 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, and the hazard involves potential content uniformity failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Burel Pharmaceuticals Inc is recalling 795 bottles of Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules. The affected product is identified by Lot # 29401501 and an expiration date of 10/17. Each capsule contains Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue 10 mg, and Hyoscyamine Sulfate 0.12 mg. The product is distributed nationwide and is available by prescription only.
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 and healthcare providers with this specific lot of Indiomin MB capsules should stop using the product and contact their pharmacist or Burel Pharmaceuticals for instructions on returning the medication.
The recalled product
- Product
- Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 795
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 # 29401501
- 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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