The U.S. arm of India's Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.
New Jersey-based Zydus Pharmaceuticals is voluntarily recalling 15,144 bottles of amlodipine besylate tablets that were manufactured by Cadila Healthcare in Ahmedabad, according to the Class III recall notice from the most recent FDA Enforcement Report. It said brown spots were seen embedded in the tablets.
In May, the Indian drugmaker recalled 10,200 bottles of its promethazine allergy pills that also were manufactured in India after the discovery of an atenolol blood pressure pill in one of them.
It has been a bad spell for recalls of blood pressure meds. In November, Canadian generics maker Apotex recalled 65,442 bottles of candesartan cilexetil made at the company's plant in Bangalore after testing found they contained excessive levels of impurities. The FDA banned the plant in April for manufacturing problems. And in October, Valeant ($VRX) recalled nearly 206,000 bottles of blood pressure medication vaseretic because of labeling problems.
- here's the Enforcement Report notice