Wholesale, retail level recalls

December 20, 2010

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recalls.

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of:

• Tylenol Cold Multi-Symptom liquid products

• Children’s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors

• Junior Strength Motrin Caplets, 24 count

• Rolaids Extra Strength Softchews, Cherry Flavor 36-count package

These recalls are not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the products.

Three Tylenol Cold Multi-Symptom liquid products, sold in the United States, will have labeling updates. An internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (<1%) amounts of alcohol.

Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors, distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas, and all product lots of Junior Strength Motrin Caplets, 24 count, that were distributed in the United States, were recalled after a review. The review revealed insufficiencies in the development of the manufacturing process.

Finally, one product lot of Rolaids Extra Strength Softchews, Cherry Flavor, 36-count package distributed in the United States, was also recalled. The recall was initiated as a precaution following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product.