FORT WASHINGTON, Pa. — In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.
All of the products were manufactured at the McNeil plant in Fort Washington, Pa., prior to April 2010, when production at the facility was suspended. McNeil stated the company has initiated the recall as a precautionary measure after an extensive review of past production records found instances where equipment-cleaning procedures were insufficient or that cleaning was not adequately documented. However, it is very unlikely that this impacted the quality of these products, McNeil stated.
McNeil also initiated a voluntary recall of certain product lots of Rolaids Multi-Symptom Berry tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language "Does not meet USP" as required by regulation.
Because the recalls are being initiated at the wholesale level, no action is required by consumers or healthcare providers, and consumers can continue to use the product, McNeil stated. These actions are not being undertaken on the basis of adverse events, the company added.