FDA Seizes More Than 30 Drugs Made By Caraco Pharma
June 25 2009 - 3:40PM
Dow Jones News
The U.S. Food and Drug Administration on Thursday said it seized
more than 30 generic drugs made by Caraco Pharmaceutical
Laboratories Ltd. (CPD) after the agency found manufacturing
defects at company plants, including oversized tablets.
Patients taking any generic drugs made by Detroit-based Caraco
should continue taking them, said Deborah Autor, director of the
FDA's office of compliance in its drug division. The company makes
a wide variety of drugs, including the popular diabetes medicine,
metformin, and the pain reliever tramadol.
Autor said patients may not realize the generic drug they are
taking is made by Caraco, but added that any defective drugs have
already been recalled or are seized.
The FDA seized the products after Caraco's "continued failure"
to ensure the quality of its manufacturing processes, Autor
said.
The FDA said the seizure may create a shortage of one medicine,
choline magnesium trisalicylate oral tablets, commonly used as pain
relievers. In that instance, physicians should switch patients to a
safe alternative.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com