Teva Recalls Cabergoline Tablets Due to Impurity Specification Failure
Teva Pharmaceuticals is recalling 13,232 bottles of Cabergoline 0.5 mg tablets because the product may not meet impurity specifications over its shelf life.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 13,232 bottles of Cabergoline 0.5 mg tablets. The affected product is identified by Lot number 6A007046V and has an expiration date of 07/12. The bottles contain 8 tablets each and are distributed nationwide.
The recall was initiated because the specific lot of product will not meet the impurity specification over its shelf life. This is a Class III recall, which the FDA defines as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Cabergoline should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is a prescription-only medication.
The recalled product
- Product
- CABERGOLINE (CABERGOLINE)
- Brand
- CABERGOLINE
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 13,232
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 number 6A007046V
- exp 07/12
Distribution
Distributed nationwide across the United States.
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