Over 330,000 bottles of Cinacalcet tablets are being recalled by Dr. Reddy’s Laboratories in the U.S. due to Good Manufacturing Practice (GMP) violations.
At a Glance
- Dr. Reddy’s Laboratories is recalling more than 330,000 bottles of Cinacalcet tablets in the U.S. due to GMP violations.
- The recall involves various strengths of Cinacalcet tablets intended to treat high calcium levels and hyperparathyroidism.
- The presence of N-nitroso Cinacalcet impurity exceeded FDA’s recommended interim limit.
- The recall was classified as Class II, indicating a moderate health risk unlikely to cause serious harm.
Details of the Recall
Dr. Reddy’s Laboratories has initiated a recall of 331,590 bottles of Cinacalcet tablets from the U.S. market. This action, commenced on October 9, became necessary after reports of impurities—specifically N-nitroso Cinacalcet—surpassing FDA-recommended limits were discovered. Distributed in strengths of 30 mg, 60 mg, and 90 mg, these tablets are used to manage conditions such as hyperparathyroidism and elevated calcium levels in patients.
The manufacturing deviations were detected during routine quality control checks, reinforcing the importance of stringent standards in the pharmaceutical sector. The U.S. market remains a critical destination for these products, evaluating impurities in pharmaceuticals underscores ongoing vigilance in safeguarding consumer health. Impacted by these findings, the drugs were all produced in India, a country ranking as the third-largest pharmaceuticals producer by volume globally.
Implications of GMP Violations
The USFDA categorized the recall as a Class II, reflecting potential temporary or medically reversible adverse health consequences. While the health risk from this recall is considered unlikely to harm patients seriously, the presence of impurities warrants immediate rectification. This recall serves as a reminder of the responsibility pharmaceutical companies have in maintaining full compliance with regulatory standards.
“Dr Reddy’s Laboratories is recalling over 3.3 lakh bottles of a medication used to treat high calcium levels in the blood and hyperparathyroidism in the U.S. market due to manufacturing issues.” – US Food and Drug Administration
Intensifying oversight and addressing contamination not only protect consumers but also safeguard the reputation of manufacturers. The Indian pharmaceutical industry is pivotal to the global supply chain, emphasizing the need for rigorous compliance with international norms.
Pharmaceutical Industry Analysis
The U.S. generic drug market, valued at over $115.2 billion in 2019, remains the largest market for pharmaceutical products, thereby requiring high-quality control. This incident involving Dr. Reddy’s highlights the broader dynamics and complexities of global pharmaceutical manufacturing. Elevated vigilance in quality assurance protocols across the industry will likely accompany further growth.
In conclusion, while Dr. Reddy’s Laboratories acts rapidly in response to the detected impurities, this recall underscores the ongoing necessity for pharmaceutical vigilance and adherence to GMP standards. As a vital contributor to healthcare, maintaining quality and safety in pharmaceuticals helps ensure trust and effectiveness across global markets.
Sources
1. Dr Reddy’s recalls over 330k bottles of generic drug in US: USFDA
2. Dr Reddy’s recalls over 3.3 lakh bottles of generic medication in U.S.: USFDA
