Watson Announces a Nationwide Voluntary Recall of Propafenone HCL Tablets Due to Oversized Tablets

FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled 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 October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product.

Read the MedWatch safety summary, including a link to the company Press Release, at:

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

abrir aquí:
Watson Announces a Nationwide Voluntary Recall of Propafenone HCL Tablets Due to Oversized Tablets