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FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Patty Eisenhaur
(951) 493-5611
FOR IMMEDIATE RELEASE -- CORONA, CA – March 23, 2009 – Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure. The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc. 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 U.S. 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.
Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have 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.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
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