Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, announced that one lot of Propafenone HCL 225mg tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure. The lot no. 112680A of the tablets is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Labs.
The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall. The company has notified the US Food and Drug Administration (FDA) of the recall.
Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so 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. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.
Patients using 225mg Propafenone HCL tablets who have medical questions should contact their health-care provider.
Watson Pharma. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of branded pharmaceuticals focused on urology, gynaecology and nephrology (medical).