Johnson & Johnson’s run of quality issues, recalls and other bad news continues with yet another product recall. The company is voluntarily recalling, at the wholesaler level, certain lots of Tylenol, Benadryl, Sudafed PE and Sinutab products distributed in the US, the Caribbean and Brazil. All of the products were manufactured at the company’s McNeil division plant in Fort Washington, which was closed in April 2010 and has been cited by the FDA as having several quality problems.
“The company is initiating 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,” explained a company statement.
The company has also initiated a voluntary recall of certain lots of Rolaids Multi-Symptom Berry Tables in the US to update the labelling. The product labelling currently does not include the language “Does not meet USP”, which is required by regulations.
“McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its US manufacturing facilities to improve the quality systems at those sites,” said the company statement.
The company submitted its Comprehensive Action Plan to the FDA in July 2010 and undertook a thorough assessment of company historical records. The assessment identified a number of areas for improvement, which are currently being addressed and have led to the latest recalls. McNeil has said that it will continue conducting assessments at other sites that manufacture its products, which may lead to further recalls if any other issues are identified.
In a statement providing an update on the plan, J&J Chairman and CEO Bill Weldon said: “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.”
J&J and its subsidiary McNeil Consumer Healthcare have been in industry headlines frequently since 2009 because of product recalls, phantom recalls and related congressional hearings. More information and background can be read in related PharmTech blogs.