INDIA – Drug major Dr Reddy’s Laboratories is recalling 2,980 bottles of Atorvastatin Calcium tablets in the US due to quality issues.
Atorvastatin is indicated to lower cholesterol in the blood for adults and children over ten years of age.
The drug is also prescribed to lower the risk of heart attack and stroke in patients with cardiovascular diseases, diabetes, and other risk factors such as eye problems, kidney diseases, or high blood pressure.
As per the US Food and Drug Administration’s latest Enforcement report, the Hyderabad-based drug major is voluntarily recalling the affected lots of the drug in 10 mg strength due to “failed impurities degradation specifications”.
The 500-count 2,980 bottles have been produced at Dr Reddy’s Bachupally (Telangana) plant and later shipped to its US arm which is now in the process of recalling the lot.
The New Jersey-based, Dr Reddy’s Laboratories Inc initiated the nationwide recall on May 4 and the USFDA has categorized it as a Class III recall which is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
In March this year, USFDA had stated that Dr Reddy’s is recalling 10,440 (90-count) and 2,24,710 (500 count) bottles of Atorvastatin Calcium tablets in the US market.
The US-based unit of the drug major initiated the nationwide recall on February 19, 2021, and the USFDA has categorized it as a Class III recall.
The drug firm had also recalled 16,449 bottles of Progesterone Capsules (200 mg), used to cause menstrual periods in women who have not yet reached menopause, in the US market for “failed dissolution specifications”.
The US is the largest market for pharmaceutical products. According to industry estimates, the US
generic market was estimated to be around USD 115.2 billion in 2019.
Cholesterol plays a huge part in development of noncommunicable diseases (NCDs) which , according to WHO, kill 41 million people each year, equivalent to 71% of all deaths globally.
Each year, more than 15 million people die from a NCD between the ages of 30 and 69 years; 85% of these “premature” deaths occur in low- and middle-income countries.77% of all NCD deaths are in low- and middle-income countries.
Cardiovascular diseases account for most NCD deaths, or 17.9 million people annually, followed by cancers (9.3 million), respiratory diseases (4.1 million), and diabetes (1.5 million).