FDA recall D-1342-2019

Chiesi USA, Inc. · Class II · drug

Product

Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.

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-1342-2019