Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities
Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.
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 FDA classified this recall as 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 Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets, 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets. The recall involves 984 blister packs with Lot 33805507A and an expiration date of 11/14. The product was distributed nationwide.
The recall was initiated because the product failed impurities/degradation specifications, specifically due to out-of-specification impurity test results. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Mircette should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 984
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 33805507A
- Exp. date 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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