McNeil Recalls Additional Over-the-Counter Products

January 20, 2011 11:56 am Topics: Over the counter and Patient safety

McNeil Consumer Healthcare has voluntarily recalled, at the wholesale level, certain lots of Tylenol^® 8 Hour, Tylenol^® Arthritis Pain, and Tylenol^® upper respiratory products, and certain lots of Benadryl^®, Sudafed PE^®, and Sinutab^® products distributed in the United States, the Caribbean, and Brazil. These products, manufactured at the McNeil plant in Fort Washington, PA, prior to April 2010 when production at the facility was suspended, are being recalled as a precaution. McNeil completed an extensive review of past production records and found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

McNeil is also initiating a voluntary recall of certain product lots of Rolaids^® Multi-Symptom Berry Tablets distributed in the US, in order to update the labeling, which does not include the language “Does not meet USP” as required by regulation.

Both of these recalls are being initiated at the wholesale level. No action is required by consumers or health care providers and consumers can continue to use the product. McNeil stresses that these actions are not being undertaken on the basis of adverse events. More information is available in a McNeil press release and on the McNeil Product Recall Information Web site.