Watson Propafenone HCL Recall Due to Oversized Tablets

The FDA has posted notice of a Propafenone HCL recall issued by the generic drug maker Watson Pharmaceuticals, Inc., for their 225mg tablets. Some 100 count bottles could have tablets that are oversized, containing too much of the active pharmaceutical ingredient. If these extra strength tablets are taken, it could cause serious side effects like low-blood pressure or arrhythmias.

Watson’s Propafenone is a generic version of the brand name heart drugs Rythmol, Rytmonorm and Propafenonum, which are used to treat cardiac arrhythmias, or irregular heart beats.

The recall only applies to one lot of Propafenone HCL 225mg tablets manufatured by Watson Pharmaceuticals, with lot number 112680A and an expiration date of July 31, 2010. Other doses sold by Watson, the brand name drugs and versions marketed by other generic drug makers are not impacted by the recall.

In a press release issued on March 23, 2009, Waston indicated that some tablets may contain higher levels of the drug than they were supposed to. The affected lot was shipped starting October 15, 2008 and could have been distributed to patients after that date.

Propafenone hydrochloride (HCL) is a very dose specific medication, with a narrow therapeutic index. Therefore, some patients could be very sensitive to small variations in the dose and the extra strength tablets could cause serious and potentially life-threatening side effects.

A propafenone overdose could cause irregular heartbeats or low blood pressure, so patients who have filed prescriptions for 225mg Propafenone HCL tablets are being urged to check the lot number and expiration date on the bottle before taking the drug.

If tablets were received from the recalled lots, patients have been advised to call their doctor and contact the manufacturer for instructions on how to return the product. However, Propafenone recall lawyers who are reviewing potential cases for individuals who experienced problems have recommended that any unused contents be kept and stored in a manner to prevent further use until after any legal claim is reviewed.

Watson is at least the third major generic drug maker to issue a recall over the last 12 months due to oversized tablets.

In April 2008, Actavis Totowa issued a Digitek recall for all lots of their generic digoxin heart drug because certain tablets may have been commercially released that contained up to twice the appropriate amount of the drug. Oversized Digitek tablets have been linked to 667 deaths between April 2008 and June 2008, and a growing number of Digitek lawsuits have been filed on behalf of individuals who experienced problems from a digoxin overdose.

Last year, Ethex Corporation also issued a recall for generic Morphine and other drugs which were found to be oversized. While the generic drug maker initially only recalled one lot of Morphine Sulfate Extended Release tablets, the recall was later expanded to include all drugs made at the plant.

There were a number of reports of morphine overdose caused by the recalled Ethex tablets, which caused side effects like respiratory depression, low blood pressure and even death in some cases.