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.
D-1342-2019
Product summary
- Firm
- Chiesi USA, Inc.
- Event
- Event 82993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2598 bottles
- Official record key
drug-enforcement:D-1342-2019
Official wording
Reason: Failed Dissolution Specifications: Out of specification result for dissolution.
Code information: Lots: 3171856, Exp. 12/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification