FDA Inspection Prompts Recall of 55 Products

-FDA News

09/05/2008- Actavis Totowa, a U.S. subsidiary of Icelandic generic drug firm Actavis, recalled all drug products manufactured at its plant in Little Falls, N.J., after an FDA inspection revealed the products were not made according to GMP standards.

“A recent inspection revealed operations which did not meet the FDA’s or Actavis’ standards,” the company said. “This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications.”

Approximately 55 different products were recalled, ranging from antiviral drug amantadine HCl to painkiller oxycodone. Tuberculosis antibiotic rifampin also was affected as well as Type 2 diabetes drug glyburide and antidepressant mirtazapine.

This action follows a previous Class I recall of Digitek (digoxin), a heart failure treatment also manufactured by the Actavis subsidiary. In that case, the drug might have contained twice the active ingredient, which could lead to digitalis toxicity.

Products made at other U.S.-based Actavis facilities, including sites in Sunrise, Fla., Baltimore, and Elizabeth, N.J., were not affected by the latest recall, the company said.

Actavis noted that blood pressure medication amlodipine besylate, antidepressant desipramine HCl, enlarged prostate drug finasteride, chemotherapy agent irinotecan HCl, anti-emetic ondansetron HCl and muscle-relaxant orphenadrine citrate were not affected by the recall.

If you are currently taking Digitek (digoxin) and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Digitek (digoxin) , without first consulting with your doctor. If you or a loved one have suffered due to DIgitek (digoxin) side effects contact the Digitek Attorneys of Ennis & Ennis, P.A. by filling out our free Digitek case evaluation form or by calling the toll-free number listed below.