Macleods Pharma Recalls Montelukast Sodium Chewable Tablets for Dissolution Failure
Macleods Pharma USA is recalling 10,680 bottles of Montelukast Sodium Chewable Tablets, 5 mg, because testing revealed low out-of-specification dissolution results in one lot.
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 III, which indicates the violation is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk issues.
Plain-English summary
Macleods Pharma USA, Inc. is recalling 10,680 units of Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles. The affected product is identified by Lot # BMD8901B and an expiration date of 02/2021. The product was distributed nationwide within the United States.
The recall was initiated because testing revealed a low out-of-specification result for dissolution in one lot of the product. Dissolution is a critical quality attribute that ensures the drug releases properly in the body; a failure in this specification may affect the drug's performance.
Consumers who have this specific lot of Montelukast Sodium Chewable Tablets should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is a prescription-only medication manufactured by Macleods Pharmaceuticals Ltd in India for Macleods Pharma USA, Inc.
The recalled product
- Product
- MONTELUKAST SODIUM (MONTELUKAST SODIUM)
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 10,680
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 #: BMD8901B
- Exp. Date 02/2021
UPCs (2)
- 0333342110077
- 0333342111074
Distribution
Distributed nationwide across the United States.
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