J&J recalls more Tylenol, other medications

By Dow Jones Newswires
Posted Jan. 14 at 3:49 p.m.

Johnson & Johnson  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  manufacturing records that the company had undertaken in the wake of earlier recalls. J&J plans to continue reviewing practices at additional plants and signaled further recalls could result.

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., before  April 2010, when production was suspended. J&J said it reviewed production records and found cases where equipment cleaning procedures were insufficient or  not documented adequately.

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 labeling. The company said the labeling didn’t include a notice that the product wasn’t tested by U.S. Pharmacopeia,  a non-governmental testing method for medicines. The FDA 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.

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 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 that the latest recalls result from a remediation plan  it had submitted to the Food and Drug Administration 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 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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  1. Chris Jan. 14 at 4:03 pm

    Funny thing about this Article……..

    Nothing is ever mention about WHERE things are manufactured? Why? Becasue its NOT IN THE US? How do I know, years back I used to work for JJ – they then, closed their LAST officially owned US plant, Neutrogena in LA.

    JJ pretty much owns very little to ZERO PPE in the US. Like P&G, et. al. They are all turning into “brand” managers……and supply nothing – Just ask who “Perrigo” is? Oh, right, the SAME suppliers who supply Walgreen’s with their Private Label Acetaminophen as they do JJ……

    Well Corp America – THIS IS WHAT YOU GET OVERSEAS……..Is it worth it? Is the long term benefit there? NOOOOOOOOOOOOO Bring back localization

  2. Good Reader Jan. 19 at 7:50 pm

    Per the fourth paragraph, the plant is in Fort Washington, Pennsylvania.