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Class I · Most seriousActive recall

Montelukast Sodium

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: MON17384, Exp 12/19
Where it was soldU.S.A. 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

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

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

Made byCamber Pharmaceuticals, Inc.
Brand nameMONTELUKAST SODIUM
Generic nameMONTELUKAST SODIUM
Active ingredient(s)MONTELUKAST SODIUM
Distributed by / forHetero Labs Limited Unit V
NDC31722-726-30
Show the full FDA record
Full product labelMontelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Recalling firmHetero Labs Limited Unit V
DistributionU.S.A. Nationwide
Quantity98016 bottles
Recall initiated2018-08-15
Report date2018-10-03
Recall completed—
Recall numberD-0081-2019
ClassificationClass I
FDA statusOngoing
Origin on fileJadcherla Mandal, Mahaboob Nagar India

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.