Drug recall
From Mary Snow
CNN
NEW YORK (CNN) -- ABLE Laboratories may not be a household name, but you'll find its generic drugs in households all over the United States.
A generic version of Tylenol with codeine, a generic version of Vicodin and a generic version of Ritalin are among the more than 40 drugs it lists as its products.
But in a matter of days, the company has spiraled downward.
"To withdraw all of your products, shut down your manufacturing plant, have your CEO take flight that day -- those are unusual occurrences," says Sharon DiStefano, an independent health care analyst who followed the company for two years.
DiStefano says ABLE Laboratories was once considered a "hot" company, reaching $100 million in sales last year. She says she was startled by what happened last week.
Thursday, the CEO resigned.
Monday, the company announced it was suspending its manufacturing operations, citing improper laboratory practices, and it initiated a recall of all its products.
Numerous calls made to ABLE Laboratories by CNN were not returned.
The Food and Drug Administration said it couldn't discuss what if any action it may be taking with ABLE Laboratories. But last year, the FDA sent a warning letter to ABLE, citing 27 reports of adverse effects of its drugs, saying ABLE did not report them.
Its recall comes at a time when the drug industry has come under scrutiny because of high profile recalls.
"This is totally different from the Vioxx and Celebrex case. This deals with how this company was manufacturing the finished product," says Kenneth Reid of FDAinfo.com.
One of ABLE's biggest products, for example, is the generic form of Vicodin -- but it is only one of 11 companies making it. ABLE is estimated to have less than 10 percent of the market share.
Reid says, "At one time, it was very difficult to tell which generic you were getting. But these days, because of labeling handed out in pharmacies, you can see the name of the company at the bottom."
