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.
D-1341-2019
Product summary
- Firm
- Chiesi USA, Inc.
- Event
- Event 82993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2118 bottles
- Official record key
drug-enforcement:D-1341-2019
Official wording
Reason: Failed Dissolution Specifications: Out of specification result for dissolution.
Code information: Lots: 3171855, Exp. 12/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification