Chiesi USA, Inc. recalls ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary…
- Recall date
- May 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1341-2019
- FDA classification
- Class II
- Brand / firm
- Chiesi USA, Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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.
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