The Food and Drug Administration (FDA) and AS Medications Solutions LLC announced a nationwide recall of all lots of the 0.25 mg. heart medication digoxin manufactured by Caraco Pharmaceuticals Laboratories distributed prior to March 31, 2009 because they may differ in size and therefore may contain more or less of the active ingredient.

ETHEX Corporation has expanded two previous voluntary recalls initially issued in 2008 to include more than 60 generic drug products at either the wholesale level or retail level as a safety precaution. The generic products may have been manufactured under conditions that “did not sufficiently comply with current Good Manufacturing Practices,” according to a press release issued by the FDA.

A heart medication sold by Mylan Laboratories in the US has had to be recalled, after it emerged that some doses may contain twice the intended dose of active ingredient. Digitek (digoxin) is used to treat heart failure and cardiac arrhythmias, and the risk of adverse events with the drug is so serious that the US Food and Drug Administration (FDA) has take the unprecedented step of asking pharmacists to notify all patients who have been prescribed it.

News about the April 2008 Digitek recall came first in the form of a brief company press release dated April 25, which was followed by an FDA MedWatch Safety Alert posted April 28 on the agency's web site. As of May 5, ten days later, there had been little additional information from Actavis Totowa, the drug manufacturer, and none from the FDA, about the possible extent of the Digitek recall.

The fact that the heart failure treatment drug Digitek (Digoxin) may contain twice the approved level of active ingredient than is appropriate has prompted Digitek recall by Actavis Totowa.