All of the medicines were produced at Dr. Reddy’s facility in Srikakulam, India, where the company is trying to address issues in drug manufacture.
The medication to be recalled is Atorvastatin calcium tablets, which is used to lower cholesterol and also to prevent heart disease.
The US Food and Drug Administration (FDA) highlighted issues with four different strengths of the tablets, which led to the recall of 55,126 bottles of the 10 mg, 44,894 of the 20 mg, 130,081 of the 40mg, and 6,397 of the 80 mg pills.
The reason for the recall was stated as “failing impurities/degradation specifications”, except in the case of the 80 mg pills that had a different issue. As part of the FDA’s Enforcement Report, the Agency provided the following reason for recall: “Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.”
When asked about the circumstances leading to the recall, a Dr. Reddy’s spokesperson commented: “We confirm that we have initiated a voluntary recall of a few batches of Atrovastatin tablets, as a matter of abundant precaution by the company, in conformance with our quality assurance norms.”
This is not the first time that Dr. Reddy’s facilities have run into trouble with the FDA, it also had issues with its Hyderabad API plant earlier this year.