Digitek has been recalled by its manufacturer, Actavis Totowa (formerly Amide Pharmaceutical, Inc.), after it was suspected that some of the tablets may contain twice the approved level of the active ingredient used in the medicine. The class I recall happened in April 2008 when the FDA had received the reports of severe illnesses amongst patients using Digitek. This medicine is a double-strength tablet that causes toxicity in the patients suffering from renal failure, and causes digitalis to accumulate inside the body, rather than passing it out through urine. This puts a lot of strain on the kidney, disrupts the proper functioning of the kidney, and further aggravates the toxicity leading to problems, such as, nausea, vomiting, diarrhoea, dizziness, low blood pressure, cardiac instability and bradycardia.

These Digitek tablets are prescribed to those patients who suffer serious heart problems, such as, irregular heartbeat, arterial fibrillation, and congestive heart failure. It is available in tablet, capsule, liquid, and injectable forms, however the Digitek recall relates only to the tablets.

de FDA had already given a warning to Actavis informing them about the danger which their medicine was posing for the patients who were administered with these pills, however despite reports of health issues in the consumers of Digitek, Actavis failed to provide them the information on how long and how many of these double-dosed pills have been in circulation. Many consumers have already filed lawsuit against Actavis for not warning the patients about the risks of consuming Digitek. It has also not been able to explain the reasons for such manufacturing faults. It is interesting to know that Actavis had received warnings from the FDA in 2006 and 2007 as well for violating the ‘Good Manufacturing Practices’ at their New Jersey plant. The letter sent by the FDA to Actavis categorically mentioned that it is difficult to ascertain whether the drugs are being manufactured using the right dosage.
There were also some out-of-specification (OSS) test results that were not documented properly and the product was released based on retesting without providing any valid reasons for ignoring the initial OSS results.

In response to the FDA’s warning letter, Actavis responded by promising to take the corrective action. While Actavis seemed sensitive towards the issue, the FDA felt that it was too late and Actavis should have been more efficient around the recall and taking prompt actions.
Pharmacies across the US have been informed about this medicine and advised them to call up the people who have purchased this medicine and inform them about the harmful side effects of this medicine.