A unit of Johnson & Johnson and Merck & Co. has recalled 12.3 million bottles of Mylanta in the U.S. and Puerto Rico because the labels failed to inform consumers about the alcohol content of the products, regulators said.
An internal review found the labels didn’t contain information that alcohol was an ingredient in flavoring agents for the over-the-counter medicines that relieve heartburn and indigestion, the U.S. Food and Drug Administration said in a Nov. 29 notice posted today on its website. Flavoring agents may contain less than 1 percent of alcohol, the notice said.
J&J, the world’s largest health-care products company, announced Nov. 24 it was recalling 9.3 million bottles of Tylenol cold treatments over labeling information on alcohol content. In April, more than 40 types of New Brunswick, New Jersey-based J&J’s children’s over-the-counter liquid medicines were recalled, forcing a suspension of production at a plant and reducing 2010 sales about $600 million, the company said in July. The U.S. House Oversight and Government Reform Committee has been investigating J&J’s handling of the April recall and a separate incident involving Motrin tablets.
“It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity-related adverse events,” the FDA notice said.
The current recall involves 12 liquid versions of Mylanta and about 84,750 bottles of Alternagel, a heartburn medicine, manufactured by Johnson & Johnson-Merck Consumer Pharmaceutical Co. at a plant in Lancaster, Pennsylvania, Marc Boston, a J&J spokesman said in an interview. The unit is a joint venture of New Brunswick, New Jersey-based J&J and Whitehouse Station, New Jersey-based Merck.
J&J rose 87 cents, or 1.4 percent, to $62.42 at 4 p.m. in New York Stock Exchange composite trading. Merck gained 59 cents, or 1.7 percent, to $35.06.
Products will be recalled from retail and wholesale locations, and consumers can continue to use the medicines, Boston said in an e-mail. The recall was not related to any safety problems with the drugs, he said.
The labeling on the products will be updated to include information about the presence of alcohol, J&J said.
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