Teva Recalls APRI Oral Contraceptive Tablets Due to Impurity Test Failures
Teva Pharmaceuticals is recalling 1,104 packs of APRI oral contraceptives 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 1/5 (Low).
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.
Plain-English summary
Teva Pharmaceuticals USA is recalling 1,104 blister packs of APRI (desogestrel and ethinyl estradiol) tablets. The product is a prescription oral contraceptive containing 0.15 mg desogestrel and 0.03 mg ethinyl estradiol per tablet. The specific lot involved is 3805324A with an expiration date of 11/14.
The recall was initiated because the product failed impurities and degradation specifications, specifically resulting in out-of-specification impurity test results. The agency has classified this as a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- APRI (DESOGESTREL AND ETHINYL ESTRADIOL)
- Brand
- APRI
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 1,104
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 (1)
- Lot 3805324A 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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