Watson Recalls Oversized Propafenone HCL Tablets Due to Overdose Risk
March 25, 2009 — Leading specialty pharmaceutical company Watson Pharmaceuticals has announced that one lot of Propafenone HCL 225 mg tablets is being voluntarily recalled from consumers. The Propafenone HCL tablets are being recalled because some tablets may be oversized, and as a result, may contain higher-than-normal levels of the active ingredient. While no adverse events have been reported to date, Watson says it is issuing the recall as a precautionary measure.
The Propafenone HCL recall affects lot number 112680A, which was shipped to customers between October 15, 2008 and November 26, 2008. The recalled tablets were sold in 100 count bottles in the United States with an expiration date of July 31, 2010. No other strengths or lots were affected and Watson does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.
Propafenone is a prescription drug used to treat illnesses associated with rapid heart beats, such as cardiac arrhythmias. Because it has a narrow therapeutic index, the recalled tablets could cause some patients who are particularly sensitive to small variations in dose to experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.
The FDA recommends that anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have the tablets being recalled. Anyone with 225 mg Propafenone HCL tablets being recalled should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product. Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.
Propafenone HCL Recall Lawyer
If you or a loved one were seriously injured by the Propafenone HCL tablets subject to the recall, you may be entitled to compensation for your medical bills, pain, suffering, lost wages, and more. To learn more about your legal rights and options, contact our Propafenone HCL recall lawyers for a free and confidential case evaluation.