Glenmark Pharmaceuticals Inc., USA has recalled 8,160 bottles of chlorproMAZINE Hydrochloride Tablets, USP 100 mg (chlorpromazine). This voluntary recall was initiated due to the presence of an impurity called N-Nitroso-Desmethyl Chlorpromazine that exceeds the FDA's recommended interim safety limits. While no specific adverse events have been reported for this product, certain nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
The tablets contain a nitrosamine impurity at levels higher than recommended. Long-term exposure to these impurities is associated with an increased risk of developing cancer.
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Product of India; Manufactured for Glenmark Pharmaceuticals Inc., USA
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 · Raw API Response
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