Teva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling
Teva Pharmaceuticals is recalling Amethyst oral contraceptive tablets because the packaging incorrectly states that Week 4 tablets are inactive, when all tablets are active.
What this means for you
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 II due to a labeling error that could lead to incorrect usage, but the hazard is limited to the potential for temporary or medically reversible adverse health consequences rather than serious injury or death.
Plain-English summary
Teva Pharmaceuticals USA is recalling 5,374 blister cards of Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispensers. The recall is due to a labeling error where the blister foil and package insert state "TABLETS IN WEEK 4 ARE INACTIVE," although all tablets in the package are active.
The affected product is Lot # 544637A, NDC-52544-295-28. The product was distributed nationwide in the USA and Puerto Rico. The tablets were manufactured by Warner Chilcott Company, LLC in Fajardo, Puerto Rico, and distributed by Actavis Pharma, Inc. in Parsippany, NJ.
Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Oral Contraceptive
- Hazard
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 # 544637A
Distribution
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