Watson Pharmaceuticals announced that one lot of 100-count bottles of Propafenone HCL 225 mg tablets, a drug used to treat cardiac arrhythmias, is being voluntarily recalled in the U.S. at the consumer level as a precautionary measure.
The lot is being recalled because some tablets may contain higher levels of the active ingredient than specified, according to the Corona, Calif.-based Watson.
The affected lot of Propafenone HCL (Rytmonorm) tablets was shipped to U.S. customers between Oct. 15, 2008 and Nov. 26, 2008-no other strengths or lots were affected, Watson said. The company has notified the FDA of the recall.
Propafenone is used to treat cardiac arrhythmias. 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 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.