FDA recall D-1341-2019

Chiesi USA, Inc. · Class II · drug

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.

Reason for recall

Failed Dissolution Specifications: Out of specification result for dissolution.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2019-05-31
Report date: 2019-06-19
Termination date: 2021-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1341-2019