Dr Reddy’s to withdraw 2,980 bottles of cholesterol reducing drug in US

India’s leading drug maker, Dr Reddy’s Laboratories is calling back its 2,980 bottles of cholesterol lowering drug, Atorvastatin Calcium medications, in the United States due to major quality issues. The drug has been indicated to lower down cholesterol in the blood of adults and children over 10 years of age.

Apart from regulating the cholesterol levels, the drug is also prescribed to alleviate the risks of health attack and stroke in patients with CVDs, diabetes, and other risk factors like kidney diseases, eye problems, or hypertension.

According to the US Food and drug Administration’s recent Enforcement report, the company is voluntarily withdrawing the affected tons of the drug in 10 mg strength subject to ‘unsuccessful impurities degradation specifications’ speculations.

The 500-count 2,980 bottles have been manufactured at the firm’s Bachupally, Telangana plant, and were later shipped to the US arm which is now in the process of withdrawing the lot.

It has been reported that the company’s New jersey arm, began the countrywide recall on May 4. Reportedly, the USFDA has characterized it as a Class III recall which was initiated in a ‘situation in which the exposure to, or use of a violative product would not cause adverse health effects.

In fact, this March, the organization stated that Dr Reddy’s was recalling 2,24,710 and 10,440 (90-count) bottles of Atorvastatin Calcium tablets from the US markets.

Apart from Atorvastatin Calcium tablets recall, the drug major had also previously recalled about 16,449 bottles of Progesterone Capsules, that were used to induce menstrual periods in women in the US market followed by ‘failed dissolution specifications’.

For the record, the US stands out to be the largest market for pharmaceutical products globally. As per industry estimates, the US generic market was reported to be $115.2 billion in 2019.

Source Credit: https://health.economictimes.indiatimes.com/news/pharma/dr-reddys-recalls-2980-bottles-of-cholesterol-lowering-drug-in-us/83279361