D-1341-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 31, 2019
- Termination Date
- March 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2118 bottles
Product Description
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 Pattern
Nationwide in the USA.
Code Information
Lots: 3171855, Exp. 12/19