Chiesi USA, Inc. recalls ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary,
Recalled June 19, 2019 · FDA recall D-1341-2019 · Chiesi USA
Hazard
Failed Dissolution Specifications: Out of specification result for dissolution. · FDA Class II
Units
2118 bottles
Sold at
Nationwide in the USA.
Description
Failed Dissolution Specifications: Out of specification result for dissolution.
Product
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.
Manufacturer(s)
Chiesi USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →