Valeant Recalls Fenoglide Tablets Due to Failed Dissolution Testing
Valeant Pharmaceuticals is recalling specific bottles of Fenoglide (fenofibrate) 120 mg tablets because they failed 24-month dissolution testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is generally associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a failure to meet quality specifications rather than a direct physical danger like choking or fire.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 3,341 bottles of Fenoglide (fenofibrate) tablets, 120 mg. The affected product is distributed by Santarus, Inc. and carries the NDC 68012-495-90. The recall covers Lot # 1300939 with an expiration date of March 2016.
The recall was initiated because the product failed 24-month dissolution testing. Dissolution testing ensures that a tablet breaks down and releases its active ingredient at the proper rate in the body. Failure to meet these specifications may mean the medication does not work as intended.
The affected product was distributed nationwide in the United States. Patients who have this specific lot of Fenoglide should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,341
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1300939
- Expiry: March 2016.
Distribution
Distributed nationwide across the United States.
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