Dr Reddy's Recalls Cinacalcet Tablets in US Over Manufacturing Issues

Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets in the US due to CGMP deviations. The presence of an impurity above FDA limits prompted the recall. Over 3.3 lakh bottles in different strengths are affected, with production linked to India.

Dr Reddy's Laboratories has announced a major recall of over 3.3 lakh bottles of Cinacalcet tablets in the United States, citing manufacturing issues.

The US Food and Drug Administration stated that the recall, affecting multiple strengths of the medication, is due to deviations from current good manufacturing practices (CGMP).

The presence of an impurity exceeding the FDA's recommended limits led to the Class II recall, which suggests temporary or reversible adverse health outcomes from use.

(With inputs from agencies.)