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Class II · ModerateRecall completed

Montelukast Sodium USP

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23
Where it was soldNationwide in the US.
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

CGMP deviations.

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 / forPD-Rx Pharmaceuticals, Inc.
NDC43063-0762-30
Show the full FDA record
Full product labelMontelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Recalling firmPD-Rx Pharmaceuticals, Inc.
DistributionNationwide in the US.
Quantity352 bottles
Recall initiated2023-04-06
Report date2023-05-10
Recall completed2024-04-30
Recall numberD-0557-2023
ClassificationClass II
FDA statusTerminated
Origin on fileOklahoma City OK 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.