Oversized Heart Pills Recalled Due to Possible Double Doses

Tablets of Propafenone HCL, a Watson Pharmaceuticals Inc. drug used to treat irregular heartbeats, have been recalled due to concerns the oversized pills may contain dangerous double doses of the active ingredient.

The recall involves one lot of the 225 mg tablets sold in 100-count bottles across the United States. The pills were shipped to customers between October 15, 2008 and November 26, 2008. Patients who take Propafenone HCL tablets are encouraged to check their bottle for the lot number and expiration date to see if their tablets are affected by the recall.

The Food and Drug Administration is assisting in the recall of the defective pills.

Propafenone is most often prescribed to patients who are particularly sensitive to small variations in dose and may experience arrhythmias (irregular heartbeats) or low blood pressure from oversized pills containing more of the active ingredient.

Other Double Dose Recalls

In 2008, Actavis Totowa recalled Digitek tablets after it was discovered some of the pills were oversized and may contain a double dose of the ingredients. The double-dose Digitek tablets posed a risk of death and severe injury to people taking the drug to prevent irregular heart rhythms. A Class I FDA recall was announced to remove all Digitek tablets from the market.

Then, in November 2008, ETHEX Corp., a marketing subsidiary fully owned by KV Pharmaceutical, and the FDA announced that nine lots of generic drugs shipped before May 22, 2008 were being recalled due to concerns about the safety of the drugs.

FDA and company officials said the recalled lots of drugs for the treatment of irregular heartbeat and low blood pressure might contain oversized tablets containing potentially life-threatening doses of active ingredients.

The KV Pharmaceutical drugs recalled were propafenone HCl, isosorbide mononitrate, morphine sulfate, and dextroamphetamine sulfate. All drugs contained in the recall have been ordered destroyed, officials said.

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