FDAMay 31, 2019drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Dissolution Specifications: Out of specification result for dissolution.
What to do
FDA enforcement status: Terminated
Brands named
chiesi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.2026-03-17
- FDAZileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.2019-05-31
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