subject: J&j Recalls 47mn Packages Of Drugs [print this page] The latest J&J recall affects certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, as well as some Benadryl, Sudafed PE and Sinutab products.
These drug lots were distributed in the United States, the Caribbean and Brazil, and were manufactured in the McNeil plant in Fort Washington, PA, before the facility was shuttered in April 2010.
The recall is initiated at only the wholesale level and will have no impact on consumers or healthcare providers. It is unlikely that the quality of the products was compromised and so consumers can continue to use the products.
In addition, another recall that involves four million packages of Rolaids Multi-Symptom Berry Tablets is underway because of incomplete labels.
J&J Chief Executive William Weldon said in a statement, "Steps we have taken under the comprehensive action plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil.
"They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world."
A safety measure
The recall is a safety measure and was issued after an internal review determined that the drugs were manufactured with equipment that may not have been properly cleaned.
The recall is initiated at only the wholesale level and will have no impact on consumers or healthcare providers.
It is unlikely that the quality of the products was compromised and so consumers can continue to use the products.
These actions are not being undertaken on the basis of adverse events, the the Food and Drug Administration (FDA) said in a statement on Friday.
Series of recalls
The latest recall is just another in the series issued by McNeil for its cold and pain relief over-the-counter medications since late 2009.
According to the FDA, McNeil had recalled approximately 288 million drug product units in 2010. These include bottles, blister packs, vials, boxes and other objects.
The problems began last January when some specific lots of a Tylenol arthritis painkiller, which was stored on shipping pallets, were found emitting a strange smell, which was linked with a nauseating chemical.
