Actavis Recalls Over 65 Generic Drugs Made at NJ Plant

On August 1, 2008, Actavis Totowa, LLC announced the recall of over 65 different generic drugs the company manufactured at the same New Jersey plant where they previously produced defective Digitek tablets which were recalled in April 2008. The recall was extended to all medications made at the plant after an FDA investigation found that the drug maker was not following good manufacturing practices.

The Actavis recall applies to products remaining on shelves at hospitals and pharmacies, but does not specifically apply to drugs which have already been given to consumers. Patients have been advised that they should not stop taking their drugs, as sudden stoppage could cause serious problems. However, if they are concerned about the quality of the medications, they have been asked to contact their doctors to discuss the alternatives.

The list of recalled generic drugs includes a variety of prescription medications, including antidepressants, diet medications, painkillers and drugs for hypertension and blood pressure. Some of the impacted generics include Amantadine 100mg capsules, Amidrine capsules, Bellamine and Buspirone tablets, Carisoprodol tablet, Meperidine and Mirtazapine tablets, Naltrexone tablets and Oxycodone capsules, Pentazocine tablets and Rifampin capsules, among others.

Actavis Totowa, LLC is a generic drug manufacturer and a subsidiary of the Actavis Group. However, the recall only applies to medications produced by Actavis Totowa LLC at the Little Falls, New Jersey plant and does not apply to any drugs manufactured by Actavis Elizabeth LLC, Actavis South Atlantic or LLC Actavis Mid Atlantic LLC.

In April 2008, Actavis issued a recall for all lots of a generic form digoxin, known as Digitek, which was manufactured at this same New Jersey plant. The Digitek recall was issued after it was discovered that tablets were being sold that were twice as thick as they were supposed to be, containing up to double the appropriate amount of the pharmaceutical ingredient.

The double strength Digitek tablets have caused hundreds of people to suffer serious health problems associated with a digoxin overdose, and a number of Digitek lawsuits have already been filed in federal and state courts alleging that Actavis knew or should have known about the manufacturing problems and product defects, which made Digitek unreasonably dangerous and unfit for its intended purpose.

Prior to the Digitek recall, Actavis received warning letters from the FDA in February 2007 and August 2006 about poor manufacturing practices at the New Jersey plant. They have been accused of failing to provide periodic safety reports, failing to properly maintain equipment and failing to maintain standards of purity, identity, quality and strength of drugs made at the plant.

In a statement published on their website late Friday, Actavis Totowa indicated that they are implementing corrective actions at the New Jersey plant to return the products to the market at a future unspecified date.