1) Children’s BENADRYL Allergy FASTMELT Tablets, in cherry and grape flavors
2) Junior Strength MOTRIN Caplets, 24 count
3) ROLAIDS Extra Strength Softchews
4) TYLENOL Cold Multi-Symptom liquid products
5) MYLANTA liquid products
6) AlternaGEL liquid product The recall in the CNMI was prompted after respective product companies, in conjunction with the Food and Drug Administration, were voluntarily recalling the products indicated above.
McNeil Consumer Healthcare, Division of McNEIL-PPC Inc. initiated a voluntary recall of all product lots of Children’s BENADRYL Allergy FASTMELT Tablets; all product lots of Junior Strength MOTRIN Caplets, 24 count after a review, conducted as part of McNeil’s Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process for such products above. According to McNeil-PPC Inc., “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.”
McNEIL-PPC Inc. also initiated a voluntary recall of one product lot of ROLAIDS Extra Strength Softchews, Cherry Flavor, 36 count packages.
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 packages.
McNeil also initiated a voluntary recall of three TYLENOL Cold Multi-Symptom liquid products in order to update the labeling for these products. McNeil Consumer Healthcare initiated the recall after 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 (
In the same month of November 2010, Johnson & Johnson-Merck Consumer Pharmaceuticals Co. also recalled twelve MYLANTA liquid products and one AlternaGEL liquid product for the same reason as that of the TYLENOL recall in order to update the labeling for such products.
JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was not noted on the packaging. Certain flavoring agents contribute small (
The codes for the recalled MYLANTA and AlternaGEL can be viewed by visiting http://www.fda.gov/Safety/Recalls /ucm235376.htm .
It is important that the public is aware that this is a wholesale and retail level recall. Consumers can continue to use the products and there is no indication that the recalled products do not meet quality standards or have any negative health effects if used.
In fact, no action is required by consumers or the Bureau of Environmental Health. However, the bureau is taking extra precautions and has advised retailers to remove all recalled items from the shelves until further notice. To date, only five retail stores were identified to have one of the recalled products (Children’s BENADRYL) and have removed them from the shelves.
Consumers with questions should call the McNeil’s Consumer Care Center at 1-888-222-6036 or the JJMCP’s Consumer Care Center at 1-800-469-5268.
The public can also get more recall information by visiting the FDA website at http://www.fda.gov/Safety/Recalls or contact the bureau at 664-4870/72, should the public have any questions or concerns about this matter.
