FDA Inspection “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices”

(Posted by Tom Lamb at DrugInjuryWatch.com)

All of a sudden it seems that the sky is falling for some generic drug companies.

On August 1, 2008 Actavis Totowa LLC announced a recall of all generic drugs manufactured at its Little Falls, New Jersey plant.

This news was first reported in the press by a late-in-the-day August 1, 2008 Associated Press (AP) article, “Company asks pharmacists, hospitals to return drug”, and the story received little to no notice over the weekend, it seems.  From that August 1 AP article:

A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” according to a company statement issued Friday.

The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension.

Actavis has issued two items related to this Little Falls plant “all-drugs” recall:

• Frequently Asked Questions – Actavis Totowa Announces Voluntary Recall at the Retail Level of all Drug Products Manufactured at its Little Falls, New Jersey Facility

• Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility [Press Release]

At this time, Actavis only wants pharmacies and hospitals to return the prescription generic drugs that were manufactured at its Little Falls, NJ plant.

Somewhat remarkably, to patients Actavis says only that anyone who may have the some of the generic medications manufactured at its Little Falls plant should continue to take them in accordance with their prescriptions, stating that suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.

Of course, the FDA constantly advises that patients should not stop taking any prescription medication before talking to your doctor. 

One would think, however, that if and when it becomes known that prescriptions drugs have been produced without adherence to Good Manufacturing Practices (GMP), a responsible drug company would be taking a more urgent tone in its advice to patients.

Only three months earlier, this same generic drug company, Actavis, was forced by the FDA to issue a Class I recall of Digitek (digoxin) pills due to a GMP problem.  If you are not familiar with the “double-dose” Digitek pills fiasco, you can get started with this article: “Digitek Update May 2008: When Old News Is Better Than No News At All — A Month After FDA Class 1 Digitek Recall, We Have Been Told Little About Actavis Manufacturing Problem”.

More generally, in mid-July 2008 I posted an article, “FDA Needs To Assure Us That There Is Quality Control For Generic Medications Sold In U.S.”, in which I posed this question:

Where is the FDA on taking steps to ascertain that Good Manufacturing Practices (GMP) are being adhered to so that our nation’s supply of FDA-approved generic drugs is safe?

The answer seems to be that our FDA is just flat-out too late as regards the many different prescription medications produced at the Actavis Little Falls.

Does anyone else sense an imminent Congressional hearing on the FDA’s oversight of generic drug manufacturers?