Novartis' ($NVS) generic division, Sandoz, is having to recall one lot of its generic version of AstraZeneca's ($AZN) blood pressure drug Atacand, but it is a copy that it does not manufacture itself. The drug is made in India by Mylan ($MYL).
According to the FDA's most recent Enforcement Report, Sandoz initiated a Class III voluntary recall of 6,336 bottles of candesartan cilexetil after testing at 18 months found the drug contained more impurities than specification allows. In Class III recalls, products are not believed to present any health danger to patients. According to the report, the product is made by Mylan at a plant in Hyderabad, India.
It is the second recall of a blood pressure med for Mylan in the last 5 months. In July, the drugmaker voluntarily recalled nearly 16,000 bottles of metoprolol succinate extended release tablets, a generic of AstraZeneca' hypertension drug Toprol XL. In that case, the recall was for an entirely different issue. "A pharmacist reported a rogue tablet of different size and markings in a bottle of metoprolol," the company reported.
The recall comes as the FDA has been looking more closely at products manufactured in India, a country that accounts for about 40% of the generic and over-the-counter drugs sold in the U.S. Mylan has a significant presence in the country and expanded that even more last year when it paid $1.6 billion for Agila Specialties, the sterile injectable business of India's Strides Arcolab.
- here's the recall notice