Published November 29. 2010 05:00PM
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYLî Allergy FASTMELTî Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRINî Caplets, 24 count, that were distributed in the United States.
This is a wholesale and retail level recall. No action is required by consumers or health care providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil's Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.The FDA, McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has also initiated a voluntary recall of one product lot of ROLAIDSî Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.This is a wholesale and retail level recall. No action is required by consumers or health care providers and consumers can continue to use the product. The recall was initiated as a precaution following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product.The affected product was manufactured by a third party for McNeil Consumer Healthcare, and the LOT number is 0053AG2, which can be found on the back of the ROLAIDSî Extra Strength Softchews, Cherry Flavor, 36 count package.Consumers with questions on any of the recalled products should call the Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. - 8 p.m. Eastern Time; and Saturday - Sunday, 9 a.m. - 5 p.m. ET.)