Zydus Pharmaceuticals (USA) Inc. is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets (10 mg), a medication used to treat certain mental/mood disorders and severe nausea. The recall was initiated because testing detected an impurity called N-Nitroso-Desmethyl Chlorpromazine at levels exceeding the recommended interim limit. This recall affects 100-count bottles distributed across 18 states.
The presence of nitrosamine impurities above acceptable limits may increase the risk of cancer if consumed over a long period of time. There are currently no reports of adverse events related to this recall.
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Manufactured by: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
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.
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Sources: FDA iRES ยท Raw API Response
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