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2012-05-03

Novartis Consumer Health initiates product recall

Public Health Announcement

Novartis Consumer Health (NCH) is voluntarily recalling all lots of select bottle sizes of Excedrin® and NoDoz® Alertness Aid products with expiration dates of Dec. 20, 2014 or earlier. Also being recalled are Bufferin® and Gas-X® Prevention® products with expiration dates of Dec. 20, 2013 or earlier, in the United States.

NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules or caplets from other products, or may contain broken or chipped tablets.

A comprehensive recall was initiated as a precautionary measure due to potential product mix-ups and is not based upon adverse events reported in relation to the recalled products.

NCH personnel believe this voluntary action is in the best interest of consumers who trust and rely on the company's products.

Consumers with questions or who have experienced an adverse event are advised to contact their physician or healthcare provider as soon as possible. Consumers should also report the adverse event to the Novartis Consumer Relationship Center at 1-888-477-2403.

As this is a voluntary recall at the consumer level, NCH advises consumers who have purchased these recalled products to discontinue use and return them to NCH for a full refund.

These actions have been communicated to the US Food and Drug Administration (FDA). "We are working closely with the FDA and will continue to do so throughout this process," said a company spokesman.

Additional information may also be found on the FDA website at www.fda.gov and at www.nodoz.com/otc/.

Consumers with questions regarding the recall should contact the Novartis Consumer Relationship Center at 1-888-477-2403, from 8 am until midnight, EST, Monday through Saturday, for information on how to return the affected products and receive reimbursement.