Class II · Moderate risk Terminated
Zileuton Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Zyflo Cr
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
What was recalled
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
- Recalling firm
- Chiesi USA, Inc.
- NDC code
- 10122-902-12
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1341-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Zileuton recalls
See all
Class II · Moderate risk Terminated
Zileuton Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification result for dissolution.
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