Clonidine Transdermal System patches recalled for impurities and degradation
Teva Pharmaceuticals USA is recalling 64,978 Clonidine Transdermal System patches (0.1 mg/day) due to failed specifications for impurities and degradation. The recall affects nationwide and Puerto Rico distribution.
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 2/5 (Moderate).
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard—failed impurities and degradation specifications—represents a potential quality defect but without documented clinical harm. Class III recalls are typically scored as 1 or 2; the presence of impurities and degradation in a pharmaceutical product warrants a score of 2 (Moderate) rather than 1.
Plain-English summary
Teva Pharmaceuticals USA is recalling Clonidine Transdermal System, USP 0.1 mg/day patches manufactured by Actavis Laboratories, UT Inc., and distributed by Actavis Pharma, Inc. The recall involves 64,978 patches from lot number 1369117B with an expiration date of 11/2021. The patches have been recalled due to failed impurities and degradation specifications.
The affected product was distributed nationwide and to Puerto Rico. Clonidine is a prescription medication delivered via transdermal patch and is used as a central alpha-2 adrenergic agonist. The NDC code for the affected cartons is 0591-3508-04.
Patients who are taking or who have received this recalled product should contact their healthcare provider or pharmacist for guidance. Consumers should not stop taking their medication without consulting their healthcare provider.
The recalled product
- Product
- CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
- Brand
- CLONIDINE TRANSDERMAL SYSTEM
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Transdermal Patch
- Affected units
- 64,978
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# 1369117B
- exp. date 11/2021
Distribution
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