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Watson Pharmaceutical Recalls Oversized Propafenone HCL Tablets

Mar 24, 2009 | Parker Waichman LLP

Watson Pharmaceuticals, Inc has recalled one lot of Propafenone HCL 225 mg Tablets because some of them may be oversized.  According to the recall notice, oversized Propafenone HCL 225 Tablets may contain higher levels of the active ingredient than specified.

According to the Food & Drug Administration (FDA), 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 at the consumer level to minimize any potential risk to patients.

The Propafenone tablets subject to this recall bear lot #112680A,  and an expiration date  of July 31, 2010.  The recalled Propafenone HCL 225 mg Tablets were sold in 100 count bottles in the United States.

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.

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 these tablets 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.

Recalls of oversized tablets are, unfortunately, not unusual.  In December, the ETHEX Corp., a subsidiary of KV Pharmaceuticals recalled a single lot of Hydromorphone HCl 2 mg tablets because some of them may have been oversized.  In November, the company  had also initiated recall of five generic drugs, including Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets, due to the potential for oversized drugs.  That action followed an October recall of  three lots of potentially oversized Dextroamphetamine Sulfate.  And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

Last April, Actavis Totowa recalled oversized Digitek tablets, some of which were made in Falls River. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure. Actavis said at the time that oversized Digitek table could expose patients to a dangerously high level of the drug’s active ingredient.  The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death.

According to a report issued by the Center for Public Integrity in December, there were 667 deaths reported to the FDA Adverse Events Reporting System that involved Digitek between April 1 and June 30, 2007.  The group also found that  FDA had received just one reported death attributed to Digitek in the three month period prior to the April recall.

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