The recall, which covers 0.125mcg and 0.25mg dosage strength batches shipped before March 31, is ironic given that Caraco was one of the firms asked to step up supply after Actavis withdrew its digoixin product, Digitek, last year.
However, Caraco is no stranger to regulatory problems. In early 2008, the US Food and Drug Administration (FDA) asked the firm to pull batches of the diabetes drug metformin and, in October, issued its Detroit facility with a warning letter.
News of the latest recall caused Caraco’s share price to fall 23 per cent to $3.25 on the American Stock Exchange, a fact that will have not gone unnoticed by majority owner India’s Sun Pharmaceuticals.