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Class III · Lower riskRecall completed

Montelukast Sodium Oral Granules USP

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # 3007556A, Exp 5/2023
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton
NDC0093-7487-56
Show the full FDA record
Full product labelMontelukast 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
Recalling firmTeva Pharmaceuticals USA Inc
DistributionUSA Nationwide
Quantity3,772 cartons
Recall initiated2023-03-27
Report date2023-04-12
Recall completed2023-08-23
Recall numberD-0510-2023
ClassificationClass III
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.