MADISON, N.J. In response to concerns voiced by a pair of Food and Drug Administration advisory panel’s concerns over uniformity in dosage delivery devices, Wyeth Consumer Healthcare on Monday announced it has initiated a voluntary recall and replacement program for all U.S. retail outlets that sell several Robitussin products and Children’s Dimetapp Cold & Chest Congestion.
The program involves removal of existing products with a dosage cup that does not have a half-teaspoon mark, which is the recommended dose for children age two to under six. This action is specific to the dosage cup and not related to the medication itself, the company stated. For children age two to under six, the company is advising consumers not to use these medicines until the replacement products with the new cup are available.
The replacement products with the new dosage cup are expected to be available beginning in early November 2007. Packaging for the replacement products will be marked to indicate that the new dosage cup is included.
The recall and replacement program for these products does not affect other Robitussin and Dimetapp cough and cold products.
Products being recalled and replaced include: