Sun Nov 03 10:49:21 UTC 2024: ## Dr Reddy’s Recalls Over 330,000 Bottles of Cinacalcet in US Due to Impurity
**New Delhi, November 3, 2024:** Dr Reddy’s Laboratories has issued a nationwide recall of over 330,000 bottles of Cinacalcet tablets in the US market due to manufacturing issues. The recall, classified as Class II by the US Food and Drug Administration (FDA), affects multiple strengths of the medication used to treat high calcium levels in the blood and hyperparathyroidism.
The recall stems from the discovery of N-nitroso Cinacalcet impurity, a substance exceeding the FDA’s recommended interim limit, within the affected batches. The impurity was detected during routine quality checks at Dr Reddy’s Laboratories, Inc., a New Jersey-based subsidiary of the Hyderabad-based pharmaceutical giant.
The recall includes 285,126 bottles of 30 mg Cinacalcet tablets, 35,880 bottles of 60 mg tablets, and 10,584 bottles of 90 mg tablets. All affected batches were manufactured in India.
The FDA categorizes Class II recalls as those where the use of the product may lead to temporary or reversible health consequences, with the probability of serious adverse effects being remote.
Dr Reddy’s initiated the recall on October 9, 2024. The company is working closely with the FDA to ensure the safe removal of the affected batches from the market.
The recall highlights the importance of stringent quality control measures in the pharmaceutical industry, especially for medications used to treat serious medical conditions.
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