More than 55,000 bottles of Amlodipine besylate and Atorvastatin calcium tablets, used to treat high blood pressure and cholesterol related diseases have been recalled by drugs major Dr Reddy's Laboratories in the US market.
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".
AdvertisementThe 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. 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. 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".
Comments from the company could not be immediately obtained. The drug is used to treat patients who have high cholesterol and certain other conditions like high blood pressure, heart blood vessel problems and chest pain.
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