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Rolaids Antacid Tablets Packaged in Bottles Recalled Due to Possible Health RisksInformation Update

2010-08

January 16, 2010

For immediate release

OTTAWA - Health Canada is informing Canadians that Rolaids antacid tablets packaged in bottles of 150 and 100 counts are being voluntarily recalled in Canada by the distributor, McNeil Consumer Healthcare (Canada), Division of Johnson & Johnson Inc. The recall comes in light of reports in the U.S. of an unusual mouldy, musty, or mildew-like odour that was, in some cases, associated with nausea, stomach pain, vomiting and diarrhea.

The distributor has confirmed that the recall does not extend beyond the Rolaids antacid tablets packaged in bottles of 150 and 100 counts. The recalled products are:DescriptionDIN/NPNUPC (EA)LOT NumbersROLAIDS® Regular Strength Original 150sNPN 02239904060093200206AAA526, ACA014, ADA269, AFA052ROLAIDS® Regular Strength Spearmint 150sNPN 02239904060093200213ABA151, ABA400, ABA401, ABA402, AEA013, ALA257ROLAIDS® Extra Strength Freshmint 100sNPN 02240505060093200237SSA156, ABA398, SSA236, ADA181, AHA044, AEA198ROLAIDS® Extra Strength Mixed Fruit 100sNPN 02240505060093200244AAA249, ACA259, AEA196, AFA318, ALA133ROLAIDS® Multi-Symptom Berry 100sDIN 02247314060245200443ABA535, AHA075

Rolaids antacids are widely used to relieve acid indigestion and heartburn. Based on an ongoing investigation by the U.S. manufacturer, McNeil Consumer Healthcare, the unusual smell has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials used in the affected product.

The health effects of this chemical have not been well studied. According to the U.S. manufacturer, all of the reactions (e.g. nausea, stomach pain, diarrhea, etc.) reported in the U.S. to date have been temporary and non-serious.

Consumers who have purchased any of the above-listed products and who have concerns about their health should speak to a health care professional. The distributor advises consumers who have purchased bottles of Rolaids antacid tablets to stop using the product and to contact McNeil Consumer Healthcare (Canada) at 1-800-661-4659, Monday-Friday 8a.m. to 8p.m. EST for instructions on how to return or replace the product. Consumers can also visit www.jnjcanada.com.

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