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Digitek, a drug used to treat heart failure and abnormal heart rhythm, was recently recalled by its manufacturer – New Jersey based Actavis Totowa LLC. The company accidentally produced pills that were double the ordinary thickness and didn’t catch the mistake until the pills were already released into the marketplace. The problem? Double the thickness also means double the strength of the pills – and double the danger to patients.

What about quality control?

How pills double their ordinary size got through the company’s quality control system is something to which many want an answer. However, all that is currently known is that the FDA sent Actavis a letter in 2006 which addressed many safety and reporting issues within the company, including:

1. Two cases where the patients’ adverse experiences had not [been] resolved when your firm received the initial reports, and in one case where only minimal case information concerning a fatal adverse event had been initially reported to your firm, there were no follow-up investigations.
2. Six potentially serious and unexpected adverse drug events dating back to 1999 for products such as Digoxin [Digitek] … that were not reported to the FDA.
3. Data received from … spontaneous reports or clinical trials were not reviewed for seriousness and expectedness.

Whether the FDA has taken any further steps to investigate the company is not yet known. To view the letter, go to: www.usrecallnews.com/FDA-Letter-Digitek.pdf

Digitek manufacturers and distributors: Who’s who?

Digitek’s list of manufacturers and distributors is enough to make anyone’s head spin. Here are the facts in a nutshell. The following three companies are involved with the digitek recall:

1. Actavis Totowa, LLC
2. Mylan Laboratories, Inc.
3. UDL Laboratories, Inc.

Actavis Totowa LLC, a division of Actavis Group located in Iceland, manufacturers Digitek in its New Jersey plant. Mylan Laboratories Inc of Pennsylvania distributes Digitek, but under the name Bertek. UDL Laboratories Inc. of Illinois also distributes Digitek, but under its own name.

For additional information, see the FDA’s press release on the recall at: www.fda.gov/oc/po/firmrecalls/actavis04_08.html/

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