Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications
Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall of a pharmaceutical product due to failed impurity specifications. The source text does not report any illnesses, injuries, or hospitalizations. FDA Class III recalls are typically categorized as 1 or 2 on the severity scale. Because this involves a drug quality issue rather than purely packaging or documentation problems, a score of 2 (Moderate) is appropriate.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Montelukast Sodium Oral Granules USP 4 mg due to failed impurity specifications. The medication failed quality control testing for sulphoxide and Impurity A.
The recall affects 3,772 cartons distributed nationwide. The affected lot is 3007556A, with an expiration date of May 2023.
Patients with this medication should contact their pharmacist or healthcare provider to determine if their supply is affected by this recall.
The recalled product
- Product
- Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 3,772
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 # 3007556A
- Exp 5/2023
Distribution
Distributed nationwide across the United States.
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