Rolaids Antacid Tablets Packaged in Bottles Recalled Due to Possible Health Risks

Starting date:

January 16, 2010

Posting date:

January 16, 2010

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110003535

• Media enquiries
• Public enquiries

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:

Description	DIN/NPN	UPC (EA)	Lot Numbers
ROLAIDS® Regular Strength Original 150s	NPN 02239904	060093200206	AAA526, ACA014, ADA269, AFA052
ROLAIDS® Regular Strength Spearmint 150s	NPN 02239904	060093200213	ABA151, ABA400, ABA401, ABA402, AEA013, ALA257
ROLAIDS® Extra Strength Freshmint 100s	NPN 02240505	060093200237	SSA156, ABA398, SSA236, ADA181, AHA044, AEA198
ROLAIDS® Extra Strength Mixed Fruit 100s	NPN 02240505	060093200244	AAA249, ACA259, AEA196, AFA318, ALA133
ROLAIDS® Multi-Symptom Berry 100s	DIN 02247314	060245200443	ABA535, 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 8 a.m. to 8 p.m. EST for instructions on how to return or replace the product. Consumers can also visit www.jnjcanada.com.

The recall is part of an expansion of an earlier U.S. recall by the manufacturer of certain Tylenol Arthritis products following reports of the same smell and stomach problems. This earlier recall did not affect products sold in Canada. Information on the earlier recall of products in the U.S. can be found in the following Health Canada Foreign Product Alert. Information on the expanded recall of products sold in the U.S. is available at U.S. Food and Drug Administration.

Consumers requiring more information about this information update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to:
    Canada Vigilance Program
    Health Canada
    AL 0701D
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709