Propafenone HCL Tabs Lot Recalled

 

March 30, 2009

March 30, 2009 - The FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of cardiac arrhythmias drug Propafenone HCL 225 mg tablets because some tablets may contain slightly higher levels of the active ingredient than specified.

Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between Oct. 15, 2008 and Nov. 26, 2008.

The Press Release includes instructions for identifying and returning the affected product.

For more information:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Propafenone