J&J recalling 12 million bottles of Mylanta

Posted Dec. 2, 2010 at 2:18 p.m.

Johnson & Johnson is adding 12 million bottles of Mylanta — the stomach discomfort treatment — to its ongoing list of recalled products, due to the presence of alcohol that’s not listed on the label.

J&J said it is recalling more than 12.3 million bottles of Mylanta and more than 84,000 bottles of AlternaGel, which is used for heartburn relief.

The company said it’s recalling the products — made in a joint venture with Merck — because “the presence of alcohol from flavoring agents was not noted on the packaging. Certain flavoring agents contribute small (less than 1 percent) amounts of alcohol.”

J&J also said, “It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity-related adverse events.” The company said it was “conducting the recall in order to update the labeling for these products.”

J&J and the Food and Drug Administration said the recall applies to 12 different Mylanta liquid products and one AlternaGel liquid product.

This is the latest in a slew of recalls from J&J of well-known consumer products. In 2009 and this year, the company’s McNeil Consumer Healthcare unit recalled millions of units of adult Tylenol, Motrin and Benadryl drugs over concerns of a moldy, musty odor.

J&J spokesman Marc Boston said the recalled Mylanta and AlternaGel bottles were produced at the J&J-Merck Consumer Pharmaceuticals plant in Lancaster, Pa.

But much of the recent trouble with other products stems from McNeil’s plant in Puerto Rico, which has been the source of numerous violations, including eight just in the last month. The violations include inadequate quality controls, lack of safeguards to isolate “rejected” raw materials and drugs, and human error resulting in product mix-ups.

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