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Possible Oversized Tablets of Five Generic Drugs Drive a Voluntary Recall by ETHEX CORP

November 11, 2008

Source: The Food and Drug Administration

The FDA and Ethex Corp issued a voluntary recall of specific lots of five generic drugs:

• Propafenone HCl Tablets (150 mg, 225 mg, and 300 mg)
• Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg)
• Morphine Sulfate Extended Release Tablets (15 mg)
• Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg)
• Dextroamphetamine Sulfate Tablets (10 mg)

These products were recalled because they may be oversized, resulting in a patient receiving as much as twice the intended dose which could cause serious or life-threatening consequences.

See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

Patients who experience any adverse reactions to these medications should contact their health care professional immediately.

Read the entire MedWatch 2008 Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ethex