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Class III · Lower riskRecall completed

Montelukast Sodium

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

Does this affect you?
Check your lot numberLot # MON16001B, Exp 01/18
Where it was soldUS 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

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

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 / forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India
NDC31722-726-30
Show the full FDA record
Full product labelMontelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Recalling firmHetero USA Inc
DistributionUS Nationwide
Quantity65,664 bottles
Recall initiated2017-01-07
Report date2017-04-05
Recall completed2017-08-08
Recall numberD-0623-2017
ClassificationClass III
FDA statusTerminated
Origin on filePiscataway NJ United States

Related

Montelukast recallsRecent drug recallsCheck another medication

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.