Vaseretic Tablets Recalled for Incorrect Package Insert Version
Valeant Pharmaceuticals is recalling Vaseretic tablets because they were packaged with the incorrect version of the package insert.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling error.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling Vaseretic (enalapril maleate and hydrochlorothiazide) 10/25 mg tablets. The recall involves 205,853 bottles of the medication, which were distributed nationwide. The specific lots affected are # 12J022P (exp. 9/30/2014) and # 13G047P (exp. 07/31/2015).
The reason for the recall is a labeling issue: the product was packaged with the incorrect version of the package insert. This is a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
Consumers who have these specific bottles of Vaseretic should contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- VASERETIC (ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE)
- Brand
- VASERETIC
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 205,853
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0301870146011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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