Dr Reddy’s Laboratories will recall over 55,000 bottles of Amlodipine besylate and Atorvastatin calcium tablets, used to treat high blood pressure and cholesterol related diseases in the US
Dr Reddy’s Laboratories is reported to have initiated a massive recall operation in the US market, as confirmed the USFDA; recalling over 55,000 bottles of its Amlodipine besylate and Atorvastatin calcium tablets. These drugs are primarily used for patients with high cholesterol and certain other conditions like high blood pressure, heart blood vessel problems and chest pain.
As per the USFDA, the company is recalling Amlodipine besylate and Atorvastatin calcium tablets in various strengths including 2.5mg/10mg, 2.5 mg/20 mg and 10mg /80 in 30 and 90 count bottles.
According to the US Food and Drug Administration (USFDA), Dr Reddy’s Laboratories, Inc, the US-based arm of Hyderabad-based firm is recalling the drug for being “sub-potent”.
The tablets being recalled by the company have been manufactured at its Bachupally facility, near Hyderabad and distributed in the US by its subsidiary, Dr Reddy’s Laboratories, Inc.
The recall was initiated by the company on August 13 this year.
The recall of the drugs has been initiated under Class-III which FDA defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences”.