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Watson Pharmaceuticals announces recall
Watson Pharmaceuticals Inc. of Corona, CA, has voluntarily recalled a lot of propafenone HCl 225 mg tablets, sold in 100-count bottles in the United States.
It's being recalled as a precautionary measure because some tablets may have higher levels of the active ingredient than indicated. The drug is used to treat cardiac arrhythmias.
Because propafenone has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias or low blood pressure.
The affected lot (# 112680A, expiration date July 31, 2010) of propafenone HCL tablets was shipped to customers between Oct. 15, 2008 and Nov. 26, 2008.
Any adverse reactions experienced when this product is used should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or on the FDA's MedWatch web site at: www.fda.gov/medwatch.