Zydus recall flags another costly bottle mixup

While drug mixups aren't unusual occurrences, that doesn't preclude them from being cumbersome and costly. Just after Pfizer ($PFE) made a massive recall in March, Indian manufacturer Zydus Cadila is now scrambling to pull 10,200 bottles of allergy pills distributed by its U.S. unit from shelves after the discovery of a blood pressure pill, the FDA said on May 28.

On May 28, the FDA issued its enforcement report on Zydus' flop, citing the presence of atenolol--the high blood pressure medication--in a bottle of the company's allergy pill, promethazine. The bottles were manufactured in India but distributed by its U.S. unit in Pennington, NJ. The FDA has classified the recall as Class II, meaning that while the presence of atenolol is not too severe, it may cause temporary or medically reversible adverse health consequences. Zydus maintains that the U.S. unit began its recall on May 8 and that it's a voluntary precautionary measure.

Pfizer had to pull 104,450 bottles of its flagship antidepressant Effexor XR, and the generic venlafaxine, after the heart drug Tikosyn was discovered in a bottle, the FDA said on March 7. Patients prescribed Effexor XR who took Tikosyn by mistake could potentially have a fatal reaction, Pfizer warned. More than 65,000 bottles had already hit pharmacies. And Pfizer is no stranger to bottling mixups: In February 2012, the company recalled 1 million packets of its birth control pills after a packaging mishap that left the active and inactive pills out of order.

But Zydus should be especially wary: The promethazine recall comes amid a widening FDA crackdown on Indian drug manufacturers for continued poor quality control. Drug products from Wockhardt plants in India have been banned by the FDA and restricted by the U.K. and EU. The FDA has also slapped import alerts on plants belonging to Ranbaxy Laboratories, India's largest generics maker, and Sun Pharmaceuticals. After suffering years of quality-control problems at Ranbaxy, its majority owner--Daiichi Sankyo--decided to sell the company to Sun Pharma.

- read the FDA enforcement report for Zydus' promethazine