FDA inspection spurs recall for troubled Actavis

Actavis recalls all drugs manufactured at N.J. plant. Source: www.theage.com.au

Actavis Totowa, maker of the defective Digitek, is voluntarily recalling more than 60 generic drug products from hospitals and pharmacies that were manufactured at its plant in Little Falls, N.J, following an FDA inspection earlier this year.

The inspection revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices. The Morristown, N.J.-based company said it has informed the FDA regarding the action.

The company claimed that the recall “is not prompted by product complaints or health hazards associated with the products, which are all prescription medications.”

The FDA revealed which products would be affected by the recall. Products manufactured by Actavis Elizabeth, Actavis South Atlantic, Actavis Mid Atlantic or Actavis products manufactured in other facilities are not being recalled.

The actions follow Actavis’ Class I recall of its heart failure treatment Digitek in May. At the time, the FDA said the Digitek defect could expose users to twice the amount of active ingredient, which could cause serious and even fatal reactions. The FDA had received 11 reports of illnesses and injuries in patients taking Digitek.

At least one law firm has already begun to seek plaintiffs in a class-action suit against Digitek makers.
   
Digitek, manufactured by Actavis Totowa, is sold by Mylan Pharmaceuticals, and under a Bertek label by UDL Laboratories.