D-1342-2019 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
- 2598 bottles
Product Description
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 Pattern
Nationwide in the USA.
Code Information
Lots: 3171856, Exp. 12/19