Dr Reddy’s recalls over 80k Atorvastatin bottles from US
Dr Reddy’s Laboratories has initiated the voluntary recalling of more than 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market due to quality concerns.
According to a notification issued by the US Food and Drug Administration (USFDA), multiple lots of Atorvastatin 10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market. Atorvastatin is a drug that blocks the production of cholesterol and reduces its level in the blood. The product is being recalled through three separate letters to the drug regulator. The product was manufactured at Dr Reddy’s Srikakulam plant in Andhra Pradesh.
Once the FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s).