Watson recalls cardiac arrhythmia drug
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.
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.