Last Updated on November 4, 2024 by The Health Master
Drug recall
Dr. Reddy’s Laboratories, a leading global pharmaceutical company, has initiated a voluntary drug recall of over 331,000 bottles of Cinacalcet tablets in the United States.
This drug recall is being undertaken due to the detection of an impurity, N-nitroso Cinacalcet, which exceeds the US Food and Drug Administration’s (USFDA) recommended interim limit.
Why the Drug Recall?
The USFDA has classified this drug recall as a Class II drug recall, indicating a potential for temporary or medically reversible adverse health consequences.
The affected lots of Cinacalcet tablets were manufactured in India and distributed across various US states.
What is Cinacalcet?
Cinacalcet is a medication primarily used to treat:
- Hyperparathyroidism: A condition where the parathyroid glands produce excessive amounts of parathyroid hormone (PTH).
- Secondary Hyperparathyroidism: A complication often associated with chronic kidney disease.
Impact on Patients
Patients currently taking Cinacalcet tablets should consult with their healthcare provider to discuss alternative treatment options.
It’s crucial to follow medical advice and avoid discontinuing medication abruptly without consulting a healthcare professional.
Dr. Reddy’s and the US Market
Dr. Reddy’s Laboratories has a significant presence in the US generic drug market, which was valued at approximately USD 115.2 billion in 2019.
The company’s operations in the US are conducted through its subsidiary, Dr. Reddy’s Laboratories, Inc., based in New Jersey.
The Future of Indian Pharmaceuticals
India’s pharmaceutical industry is a global powerhouse, ranking third by volume and fourteenth by value.
It’s essential for Indian pharmaceutical companies to prioritize quality and adhere to stringent regulatory standards to maintain their position in the global market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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