McNeil Consumer & Specialty Pharmaceuticals has issued an alert that one manufacturing lot of Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain an adult dose of acetaminophen--Tylenol 8-hour extended release Geltabs.
The lot number being recalled is JAM108, with an expiration date of 1/06. The lot number is embossed on the carton flap and printed on the label of each bottle. The lot was distributed nationwide to wholesale and retail customers between Feb. 5 and April 1, 2004.
The mislabeled bottles appear to be the result of a packaging error for the one lot. There were 75,000 bottles in the lot, but not all die bottles were affected. As of May 2004, two mislabeled bottles had been identified and no injuries had been reported.
Children's Motrin Grape Chewable Tablets are round, purple, scored tablets with the letters MO and the number 50 on the tablet surface. These tablets have a non-glossy finish and a simulated grape-like smell. The Tylenol 8-hour Geltabs are hard, round, gelatin coated, and shiny. The tablets are white on one side, red on the other, with "8 Hour" printed in blue on either side.
Consumers who discover any bottles in this lot should contact McNeil's consumer relationship center at (800) 962-5357. Parents who believe their children may have taken Tylenol 8-hour Geltabs, believing them to be Children's Motrin chewable tablets, should contact their health care provider or a poison control center immediately.
COPYRIGHT 2004 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group