On April 30, 2010, unexpired lots of Children's and Infants' liquid Motrin® were recalled by the U.S. Food and Drug Administration (FDA) and the products' manufacturer. The manufacturer, McNeil Consumer Healthcare, said in a press release that the recall was voluntary because "some of these products may not meet required quality standards." McNeil Consumer Healthcare, a division of McNeil PPC, Inc., is a subsidiary of Johnson & Johnson.
The press release went on to say that the recall was not due to the occurrence of adverse medical events, but as a precautionary measure because:
The release did not state what the tiny particles consisted of.
Children's Motrin® is classified as a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, pain, inflammation and swelling caused by a variety of medical conditions. The manufacturer states there are certain increased risks associated with long-term use of NSAIDs. These risks include:
NSAIDs also have been linked to a rare, allergic skin disorder named Stevens-Johnson Syndrome (SJS). The disorder affects all ages. This is a life-threatening condition that is characterized by:
Before the rash and flaking skin appear, SJS patients typically feel like they're coming down with the flu. They may have a fever, sore throat, body aches, headache and cough. The face and tongue swell. The affected skin may be confined to one area or cover most of the body surface.
The condition is similar to a severe thermal burn and patients are best treated in a hospital burn unit where they can receive intravenous fluids, salts and nourishment. The raw areas of skin where the upper layers of tissue have sloughed off are covered with cool soothing compresses.
It is essential to prevent the wounds from becoming infected, since the infection could become systemic and eventually cause organ failure and death.