Key Points
- Dr Reddy’s is recalling 331,590 bottles of Cinacalcet tablets in the US.
- The recall is due to an impurity called N-nitroso Cinacalcet that exceeds FDA limits.
- This includes 30 mg, 60 mg, and 90 mg strengths.
- The recall is classified as Class II, meaning it could lead to temporary health issues.
- The recall started on October 9, 2023.
- The US market for generic drugs was worth about $115.2 billion in 2019.
Looma News
Dr Reddy’s Laboratories is recalling over 330,000 bottles of Cinacalcet tablets from the US market due to production issues. The US Food and Drug Administration (FDA) reported that 331,590 bottles are affected because they contain N-nitroso Cinacalcet, which is above the recommended safety limits.
The recall includes 285,126 bottles of the 30 mg strength, 35,880 bottles of the 60 mg strength, and 10,584 bottles of the 90 mg strength. All of these products were made in India.
This recall has a Class II rating, which means that using the product might cause temporary or reversible health effects, but serious health problems are unlikely. Dr Reddy’s Laboratories, Inc., based in New Jersey and part of the Hyderabad-based company, started the recall on October 9, 2023.
India’s pharmaceutical industry is the third-largest in the world by volume and ranks fourteenth in value. The US market for generic drugs is the biggest globally, worth around $115.2 billion in 2019.
