Wockhardt Ltd., the Indian drugmaker whose biggest revenue-generating facility was banned by the U.S. Food and Drug Administration last year, is recalling some bottles of its generic version of the heart pill Toprol XL.
The U.S. recall initiated by the Mumbai-based company April 1 targets 109,744 bottles of the drug, known generically as metoprolol succinate, after failed dissolution tests, according to an enforcement report posted on the FDA’s website.
Wockhardt had two Indian facilities placed on the regulator’s import-alert list last year. At one of them, which manufactured metoprolol, FDA inspectors found faulty quality controls and raw-material storage areas with mold growth. The agency has ramped up efforts to monitor the safety and quality of generics, particularly those made abroad, in the last year.
The FDA is planning an extensive study of generic Toprol XL, which generates almost 40 million prescriptions a year. Complaints against the drug cite both a lack of effectiveness and troublesome side effects, according to a review of 3,425 adverse incident reports by Bloomberg News.
Wockhardt shares fell 0.9 percent to 789 rupees at 1:28 p.m. in Mumbai trading. Dominic D’Souza, a spokesman for the company, had no immediate comment when reached by phone.