Digitek Digoxin Recall

Actavis, Inc Re-opens Little Falls, NJ Plant
April 2009

Back in December of 2008, the FDA and Actavis reached an agreement that the manufacturing plants in Totowa and Little Falls, NJ would halt production and shutdown. These plants were involved in manufacturing the recalled heart medication, Digitek.

Now, Actavis has re-opened the Little Falls plant, although not quite the capacity at which it once was. They will be manufacturing only one product, Oxycodone, in two different strengths.

"Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," said Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis Inc. "This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products...."

Will Digitek be among them?

"Our customers come first," said Doug Boothe, CEO of Actavis Inc. Regarding the recall, he mentioned, "We are sorry for the inconvenience the recall caused for some but as a company, we are committed to producing high quality pharmaceuticals, and that's what we will continue to do."

Inconvenience? Man, is that an understatement!

Read the source article from Business Wire.

Actavis Denies That Double-Dose Pills Ever Reached The Public
December 24, 2008

"Never underestimate the power of denial." ~Wes Bentley
I've often heard it said that when you've been caught red-handed, the best thing to do is deny, deny, deny. Actavis, Inc. must be familiar with this little piece of advice, as well. Now that the claims against them regarding their double-dose Digitek pills are mounting, they deny any responsibility for numerous injuries and deaths due to digoxin poisoning. In a comprehensive article from Jeanne Lenzer at The Center for Public Integrity, "Actavis maintains that none of the improperly manufactured pills ever reached the public." They just decided to do a Class I recall, the stiffest of all recalls, spanning a two year period out of an "abundance of caution."

Phew! Thanks Actavis!

But not so fast. The recall was issued in April of 2008, but it was intended to cover all Digitek pills manufactured from March 2006 through April 2008. Are they really so sure that over two years time, none of the defective pills reached the public? What does the FDA have to say about it? In Did The FDA Miss Signals on a Troubled Drug? Lenzer reports,

"The FDA has had concerns about Actavis that go well beyond Digitek. Five FDA inspections in 2006 and 2007 of three Actavis Totowa plants in New Jersey - two in Totowa and one in Little Falls - uncovered shoddy manufacturing practices and numerous 'longstanding' quality control and reporting violations dating back to 1999 in regard to various drugs produced by the firm. During an August 2006 inspection, the FDA said it was impossible for Actavis to reliably ensure that their pills even contained the drug they said they contained. In a warning letter dated February 1, 2007, the FDA wrote that there was no assurance that many of the company's drugs 'have the identity, strength, quality and purity that they purport to possess.' Record keeping by the company was equally poor. Company records had been altered or 'overwritten' and undesirable or 'out of specification' test results were simply discarded and replaced with newer test reports 'without any justification' for discarding the earlier results, according to the inspection report."

So the FDA inspection report said that Actavis had no way of knowing that one pill wasn't actually some other pill, but Actavis still maintains that none of the defective pills reached the public. Sounds like they couldn't have even confirmed that Digitek pills were in Digitek bottles! Inferring from the FDA inspection, digoxin very well could have been in their Prenatal Vitamin tablets.

Just remember, deny, deny, deny. Seems to be working so far.

Along these same lines, Lenzer asked the FDA why, upon finding such serious conditions at the Actavis facilities back in 2006, they did nothing about it. The FDA replied, "when questions regarding these deficiencies were raised by the FDA, the firm elected to voluntarily recall all the products manufactured at this facility."

You know, that is true. Only, the recall did not happen until 2 years later.

In response to the sheer number of adverse event reports made to the FDA, Actavis points to the fact that many adverse reactions were reported "in May - June -July, after the recall was announced." And regarding deaths, "We do not know what caused those deaths, and there is no evidence that Digitek was in any way to blame." But Lenzer is not so quick to accept this answer. She points out that in the event of a recall of Class I magnitude, the FDA is supposed to go to great lengths to inform the public. However, Lenzer says:

"What the FDA posted on its MedWatch website was not a statement from the agency, but a news release written by Actavis. Regardless of who writes them, such postings are easily missed by the public and journalists, health experts say. For serious problems, they say, the FDA usually sends e-mails to journalists and holds a news conference. In 2004, when the painkiller Vioxx was found to cause heart attacks, the agency not only issued its own news releases, but also held hearings that resulted in an avalanche of news coverage. But in the case of Digitek, the FDA never issued its own news release, nor did it hold a news conference."

"Some, but not all, pharmacies called or mailed notices to patients taking Digitek. Many patients posting messages on consumer-focused websites say they received the notices weeks after the recall or not at all. Nor did the company or the FDA send warning alerts to physicians."

"Furberg, a former member of the FDA's Data Safety and Risk Management Advisory Committee, said problems with Actavis indicate a 'total failure of the system to oversee the production of medications and follow up on recalls.' He called the agency's posting of the Actavis news release on its MedWatch website 'inadequate,' and said that the FDA 'should have issued an alert or asked the manufacturer to issue an alert to be sent to all physicians.'"

But, of course, Actavis maintains that none of the defective pills ever reached the public, so I guess there wasn't much reason to be sure the public knew about it, right?

Lenzer finishes the article with a crucial point. Actavis and the FDA have been approaching the Digitek "double-dose pill" problem backwards, "the FDA should act to protect the public, unless and until it is substantially shown that there is no danger - rather than taking no action until someone can 'prove' that there is danger." Before any pills are on the shelf, they must be proven safe, something which the 2006/2007 inspection reports already show they clearly were not. A manufacturing company with a substantial history of direct FDA violations, violations which assert that Actavis couldn't even distinguish which pills were which, cannot displace the burden of proof elsewhere. Given their record, by what means can Actavis, Inc. truthfully claim that none of the defective pills ever reached the public?

I strongly suggest that you go and read the full article entitled, Did The FDA Miss Signals on a Troubled Heart Drug?

Actavis Facing Possible Shutdown
December 4, 2008

After having failed FDA inspections time and time again, the FDA is finally making a move to shut down one of the Actavis, Inc. facilities: Actavis Totowa LLC. Actavis Totowa is the manufacturing company of Digitek pills. As you may or may not know, Actavis did a massive recall of its Digitek pills back in April of 2008 because they were oversized and presumed to contain a "double-dosage." Now, mistakes and oversights like this are catching up to them.

In an inspection earlier this year, the FDA found several problems. However, the company maintains that since May 2008 they have been working hard to comply with all of the FDA's regulations.

Since May 2008?

An article by Marley Seaman states, "In the inspections, the FDA found the company kept incomplete lab records of its testing data, and failed to verify that its testing methods matched up with actual conditions under which the products would be used. It also did not investigate unusual test results, didn't follow its own stability testing procedures, and didn't make sure test samples met its specifications."

The list of problems goes on. But don't worry. Actavis has been working hard to remedy the situation and make sure that they are in strict compliance with FDA standards...that is, since May.

If you would like to read Actavis' comments try this article from Business Wire.

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