Johnson & Johnson (JNJ) recalled nearly 47 million units of over-the-counter medicines Friday, the latest in a string of quality-related product recalls.
J&J said the latest recall resulted from a thorough examination of historical manufacturing records that the company had undertaken in the wake of earlier recalls. J&J plans to continue reviewing practices at additional manufacturing sites and signaled further recalls could result if more issues surface.
The New Brunswick, N.J., company said it was recalling 42.9 million bottles of certain Tylenol, Benadryl, Sudafed and Sinutab products distributed in the U.S., the Caribbean and Brazil.
J&J said these products were made at its McNeil Consumer Healthcare plant in Fort Washington, Pa., prior to April 2010, when production was suspended. J&J said it reviewed past production records and found cases where equipment cleaning procedures were insufficient, or cleaning wasn't adequately documented.
J&J said it was "very unlikely" these issues affected the quality of the recalled products.
In addition, J&J recalled 3.9 million bottles, rolls and packages of Rolaids antacid distributed in the U.S., to update the product labeling. The company said the labeling didn't include a notice that the product wasn't tested by U.S. Pharmacopeia, which is a non-governmental testing method for medicines. The Food and Drug Administration doesn't require the use of USP, but labels on products that don't use this testing are required to include the language "Does not meet USP," said McNeil spokeswoman Bonnie Jacobs.
The company said the latest recalls were at the wholesale level, and that no action is required by consumers or healthcare providers. Consumers can continue to use the products, J&J said.
J&J has issued a series of recalls of over-the-counter medications since late 2009, citing quality problems such as excessive concentrations of active ingredients, and floating metal specks.
The recall has cost J&J hundreds of millions of dollars in lost sales and related costs, and the U.S. Justice Department has launched a criminal probe of issues related to the recalls.
J&J said Friday the latest recalls results from a key element of a remedial plan that it had submitted to the FDA in July 2010.
The company said it completed a thorough investigation of historical records, as far back as 2007, for products sold in the U.S. and produced in McNeil's internal manufacturing network.
McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met for each product. The assessment identified a number of areas for improvement, which are being addressed, including the equipment-cleaning issue cited for the latest Tylenol recall.
The latest recall wasn't caused by any adverse event reports, J&J said.
McNeil is conducting assessments at other sites that manufacture its products. If these reviews reveal any further issues, McNeil said it would take steps to ensure that its products meet high quality standards, "including further market action if warranted."
"Steps we have taken under the comprehensive action plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil," J&J Chief Executive William Weldon said in a statement. "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 shares fell 36 cents to $62.55 Friday.
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