Dr. Reddy's Laboratories, Inc. is voluntarily recalling approximately 331,590 bottles of Cinacalcet Tablets in 30 mg, 60 mg, and 90 mg strengths. This recall was initiated due to the presence of an impurity called N-nitroso Cinacalcet that was found to be above the FDA's recommended interim safety limit. Cinacalcet is a prescription medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as high calcium levels in patients with parathyroid cancer.
The recall is due to test results showing levels of the impurity N-nitroso Cinacalcet that exceed safety standards. While short-term exposure is not expected to be hazardous, long-term exposure to these impurities at higher-than-recommended levels may potentially increase the risk of cancer.
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Sources: FDA iRES · Raw API Response
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