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Class II · ModerateRecall completed

Zileuton Extended-Release Tablets

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

Does this affect you?
Check your lot numberLots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Where it was soldProduct was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product 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 Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

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 / forLupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India
NDC68180-169-16
Show the full FDA record
Full product labelZileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Quantity3,216 bottles
Recall initiated2022-06-10
Report date2022-06-22
Recall completed2023-02-08
Recall numberD-1150-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD 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.