Dr. Reddy’s Laboratories has initiated a massive recall of over 330,000 bottles of Cinacalcet tablets in the United States due to manufacturing issues and impurity levels exceeding FDA guidelines.
At a Glance
- Dr. Reddy’s Laboratories is recalling 331,590 bottles of Cinacalcet tablets in the U.S.
- The recall is due to CGMP deviations and high levels of N-nitroso Cinacalcet impurity.
- Affected bottles include 285,126 of 30 mg strength, 35,880 of 60 mg strength, and 10,584 of 90 mg strength.
- The recall, initiated on October 9, is classified as Class II by the FDA.
Manufacturing Issues Lead to Massive Recall
Dr. Reddy’s Laboratories, a major player in the pharmaceutical industry, has announced a significant recall of Cinacalcet tablets in the United States market. The recall affects over 330,000 bottles of the medication, which is used to treat high calcium levels in the blood and hyperparathyroidism. The recall stems from manufacturing deviations that resulted in impurity levels exceeding the guidelines set by the U.S. Food and Drug Administration (FDA).
“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,” the US Food and Drug Administration said.
The recall specifically involves 331,590 bottles of Cinacalcet tablets in various strengths. The breakdown includes 285,126 bottles of 30 mg strength, 35,880 bottles of 60 mg strength, and 10,584 bottles of 90 mg strength. All affected lots were produced in India, highlighting the global nature of pharmaceutical supply chains and the challenges they present in maintaining consistent quality standards.
Impurity Levels Exceed FDA Guidelines
The primary reason for the recall is the “presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit,” according to the US Food and Drug Administration. This deviation from Current Good Manufacturing Practice (CGMP) standards has prompted swift action to remove the affected products from the market.
The FDA has classified this as a Class II recall, which indicates that while the situation is serious, the potential for adverse health consequences is relatively low. Class II recalls typically suggest that exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
Impact on Patients and the Pharmaceutical Industry
Cinacalcet plays a crucial role in managing conditions such as hyperparathyroidism and elevated calcium levels. Patients currently using these medications should consult with their healthcare providers to determine the best course of action. It’s important to note that abruptly stopping medication can be dangerous, and decisions should be made under medical supervision.
The recall sheds light on the ongoing challenges faced by the global pharmaceutical industry, particularly in the generics sector. The Indian pharmaceutical industry, which ranks third-largest by volume and 14th by value globally, plays a significant role in the U.S. generic drug market. With the U.S. market valued at approximately $115.2 billion in 2019, maintaining stringent quality control is paramount for international pharmaceutical companies looking to maintain their market share and reputation.
Be careful out there.