Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures
Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, prescription only. The affected product is identified by NDC 0378-6040-93, Batch 3074707, with an expiration date of 02/2018. The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for Sulphoxide Impurity and Total Impurities.
The product was distributed nationwide. This recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should discontinue use of the affected product and contact their pharmacist or healthcare provider for guidance on alternative treatments or returns.
The recalled product
- Product
- Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 11,624
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)
- Batch 3074707
- exp 02/2018
Distribution
Distributed nationwide across the United States.
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