Recalls / Class II
Class IID-0163-2016
Product
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
- Affected lot / code info
- Lot # 1300939, Expiry: March 2016.
Why it was recalled
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 3341 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-09-04
- FDA classified
- 2015-11-03
- Posted by FDA
- 2015-11-11
- Terminated
- 2017-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0163-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.