Drug product
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
D-0163-2016
Product summary
- Event
- Event 72214
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3341 Bottles
- Official record key
drug-enforcement:D-0163-2016
Official wording
Reason: Failed Dissolution Specifications: Failed 24 month dissolution testing.
Code information: Lot # 1300939, Expiry: March 2016.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications