Why it was recalled
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Product description
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Lot numbers, UPCs & expiration codes
Lot # 1300939, Expiry: March 2016.
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0163-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2015
- FDA report date
- Nov 11, 2015
- Quantity
- 3341 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0163-2016, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 72214
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot # 1300939, Expiry: March 2016.
- Postal code
- 08807-2867
- Report date
- Nov 11, 2015
- Product type
- Drugs
- Recall number
- D-0163-2016
- Classification
- Class II
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 3341 Bottles
- Termination date
- Mar 14, 2017
- Reason for recall
- Failed Dissolution Specifications: Failed 24 month dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 3, 2015