WASHINGTON, July 14 (UPI) -- The U.S. Food and Drug Administration says all lots of concentrated acetaminophen drops distributed by Brookstone Pharmaceuticals LLC are being recalled.
The FDA said the Alpharetta, Ga., company initiated the nationwide voluntary recall because the 16-ounce bulk containers are comparable to the size generally used to package regular strength acetaminophen liquid preparations.
"This aspect of the product, coupled with the absence of an integrated dosage delivery device, is a contributing factor to possible dosing errors, especially inadvertent overdosing," the FDA said in a statement.
Brookstone said it distributed 344 bottles nationally and has donated 5,301bottles to charity for international distribution.
Over dosage of acetaminophen can result in liver toxicity, kidney damage and blood disorders, the FDA said. Agency officials said they are aware of several reports that document life-threatening or fatal adverse events due to confusion associated with the concentrated versus regular strength acetaminophen liquid.
Consumers with questions can contact the company at 800-541-4802.
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