Chattem Inc is recalling 129,240 bottles of Unisom SleepMinis (diphenhydramine HCl), a 25 mg sleep aid. The recall was initiated because testing detected a nitrosamine impurity called N-nitroso-desmethyl-diphenhydramine at levels higher than the daily limit recommended by the FDA. The affected product is sold in bottles containing 60 mini-capsules and was distributed to retailers across the country.
Nitrosamines are chemicals that are classified as probable human carcinogens, meaning they may increase the risk of cancer with long-term exposure above safe levels. While no injuries or illnesses have been reported to date, the levels found in these specific lots exceed government safety guidelines.
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Recall initiated due to CGMP deviations and detection of NDSRI above intake limits.
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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