Safety Alerts & Recalls

What does this mean?

Since propafenone has serious side effects if overdosed, this recall should be taken seriously. These side effects include irregular heartbeats (arrhythmias) and low blood pressure.

If you or someone you care for is taking propafenone tablets, check your bottle to see if they were made by Watson Pharmaceuticals and if it is labeled with lot number 112680A. The prescription bottle often lists the manufacturer on the pharmacy label and sometimes also lists the lot number. If you think your tablets are made by Watson Corporation you should return them to your pharmacy to examine and possibly exchange. If you are not sure who has made your tablets, please take your bottle to your pharmacist for them to check as soon as possible.

You can also call Watson Pharmaceutical Customer Service (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for additional instructions on how to return affected product.

If you have any medical questions about propafenone or if you are experiencing side effects, you should contact your physician, pharmacist, or other health care provider as soon as possible.

Recall on Single Lot of Propafenone 225 mg Tablets

Watson Pharmaceuticals, Inc has voluntarily recalled a single lot of PROPAFENONE (also called Rythmol) 225 mg tablets. Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). These tablets may be oversized and could result in patients receiving more than the expected dosage of this drug

The lot number involved in the recall is lot number 112680A, expiration date July 31, 2010.

No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-03-24
Last Updated: 2009-12-05

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