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Class II · ModerateRecall completed

Montelukast Sodium Tablets

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

Does this affect you?
Check your lot numbera) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .
Where it was soldNationwide in the USA
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 / forDirect Rx, Dawsonville, GA 30534
NDC61919-0009-30
Show the full FDA record
Full product labelMontelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Recalling firmDirect Rx
DistributionNationwide in the USA
Quantity90 count: 495 bottles; 30 count: 13 bottles
Recall initiated2023-03-13
Report date2023-04-05
Recall completed2024-06-17
Recall numberD-0476-2023
ClassificationClass II
FDA statusTerminated
Origin on fileDawsonville GA 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.