Teva Recalls Kariva Tablets Due to Out-of-Specification Impurity Test Results
Teva Pharmaceuticals is recalling 1,125 blister packs of Kariva tablets because impurity test results were out of specification.
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: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, aligning with the 'Moderate' severity for minor quality control issues without reported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling 1,125 blister packs of Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) tablets. The affected product is Lot 33805325A, with an expiration date of 11/14. The recall was initiated because the product failed impurities/degradation specifications, specifically due to out-of-specification impurity test results.
The recalled product is distributed nationwide. Kariva is a prescription-only medication available in 6 cyclic dispensers containing 28 tablets each (0.15 mg/0.02 mg and 0.01 mg). The NDC for the affected package is 0555-9050-58.
Consumers with this specific lot of Kariva should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL)
- Brand
- KARIVA
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- Affected units
- 1,125
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 33805325A
- Exp.11/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA 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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