Actavis Tells Us More, But Not Much More, About April 2008 Digitek Recall

Actavis, Mylan, Or The FDA Should Tell Public Their Current Estimate Of How Many Defective Digitek Pills Were Distributed To Pharmacies, And During What Time Period

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 9, 2008 Actavis North America issued this press release "Digitek® recall – customer support and frequently asked questions", which looked like it contained some new information about the Digitek recall.

But on the critical issue of how extensive is the Actavis manufacturing problem which led to the FDA recalling Digitek (digoxin), the company is still vague in terms of quantity and time, saying no more than this is an "all-lot" recall.

From speaking with patients around the country who have taken Digitek the past couple of years, it seems that this Digitek recall is not limited to only those digoxin tablets which were manufactured by Actavis a month or two before the company's April 25, 2008 announcement about the Digitek pill manufacturing problem it had discovered.

What these patients and their families deserve to know is an estimated number of defective Digitek pills that were distributed by Mylan Pharmaceuticals to pharmacies under the "Bertek" and "UDL" labels, as well as the period of time when one might have been taking a Digitek pill that had double the intended dose of digoxin.

As we learned from a "recall notice" posted on the North Carolina Board of Pharmacy (NCBOP) web site, the Bertek Digitek pills might have had the double-dose problem as far back as March of 2006.  But this is all we know.

Is this all that Actavis, Mylan, and the FDA know?