Maker of Defective Digitek Recalls All Generic Drugs Made at New Jersey FactoryAug 4, 2008 | Parker Waichman LLP
Actavis Totowa, the maker of defective Digitek tablets, has announced a recall of all generic drugs manufactured at its plant in Little Falls, New Jersey.
According to the Food & Drug Administration (FDA) notice, the recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA's standards for good manufacturing practices. Actavis Totowa is asking pharmacies, hospitals and retailers to return the affected prescription medications.
The list of recalled medications is available here. Actavis has issued this recall at the retail level only. The company says patients should continue to take their medications as directed. However, anyone who wishes to have their medicines replaced should consult their healthcare provider.
The generic drug recall is limited to Actavis Totowa products and products manufactured in other Actavis facilities are not affected.
In April, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek involved in this earlier recall was made at the New Jersey facility.
The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. But because not all adverse reactions are reported to the FDA or manufacturers, the true number could be much higher.
The FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J.