Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
ZYFLO CR (zileuton)
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDC
10122-0902-12
Compare with the code on your package — it is the most precise check available.
Drug: Zileuton
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zileuton recalls
See all
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
Other recalls by Chiesi USA, Inc.
All 2019 recalls
Class III · Low risk
Revcovi (elapegademase-lvlr)
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class II · Moderate risk
CLEVIPREX (clevidipine injectable emulsion)
Lack of Assurance of Sterility
Class II · Moderate risk
CUROSURF (poractant alfa)
Lack of Assurance of Sterility
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
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