Dr Reddy's Labs recalls over 3 lakh bottles of Cinacalcet tablets in US over manufacturing issues
New Delhi: Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets, a medication used for treatment of high calcium levels in the blood and hyperparathyroidism, in the U.S. market over manufacturing issues.
The U.S. Food and Drug Administration (FDA) Enforcement Report states that Dr. Reddy's is recalling 331,590 bottles of Cinacalcet tablets in various strengths due to deviations from current good manufacturing practices (CGMP) in the American market. The recall is due to the presence of N-nitroso Cinacalcet impurity above the FDA recommended interim limit.
Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.