Teva Pharmaceuticals USA is recalling 5,374 units of Amethyst (levonorgestrel and ethinyl estradiol) birth control tablets because the packaging contains incorrect instructions. The blister foil and package insert mistakenly state that "TABLETS IN WEEK 4 ARE INACTIVE," when in reality, all 28 tablets in this continuous-cycle regimen are active medications. This labeling error could lead consumers to believe they are taking placebo pills during the fourth week of their cycle, potentially causing confusion regarding their medication schedule. Consumers should contact their healthcare provider or pharmacist for guidance on how to proceed with their prescription.
The incorrect instructions may cause patients to treat the fourth week of their medication as inactive/placebo days, which could lead to dosage errors or confusion about the continuous-cycle nature of the drug. While all tablets are actually active, following the incorrect 'inactive' instruction may result in patients not understanding their full treatment cycle.
Contact healthcare provider and return product to pharmacy.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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