FDA-Drug2019-06-19Class II
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.
Chiesi USA, Inc.
Hazard
Failed Dissolution Specifications: Out of specification result for dissolution.
Sold states
Nationwide in the USA.
Affected count
2118 bottles
Manufactured in
175 Regency Woods Place, Ste. 600, N/A, Cary, NC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1341-2019Don't want to check this manually?
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