Nationwide Recall of Certain Over-The-Counter Products

Novartis Consumer Health has recalled all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expire dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expire dates of December 20, 2013 or earlier, in the United States. This action is being taken because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. See the list of affected products at the end of this release.

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Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. The company is not aware of any reports of adverse events associated with the recalled products.

All of the pills in the bottle should look the same. If consumers find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Consumers who have the affected product(s) should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 6 a.m. to 5 p.m. Pacific Time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers should visit the company’s website at www.novartisOTC.com.

Any adverse events that may be related to the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program. The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500. The form may be downloaded from www.fda.gov/MedWatch/getforms.htmand mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178.

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The Monterey County Health Department releases notices of recalls and market withdrawal from the firms involved as a service to Monterey County residents, the media and other interested parties. The Health Department does not endorse either the product or the company.

Products affected by January 9, 2011 Novartis Recall

All lots of Bufferin® products with expire dates of December 20, 2013 or earlier

Bufferin® Extra Strength Tablets
Bufferin® Low Dose Tablets
Bufferin® Regular Strength Tablets

All lots of the following Excedrin® products have been recalled with expire dates of December 20, 2014 or earlier

Excedrin® Extra Strength Caplets
Excedrin® Extra Strength Express Gel Caplets
Excedrin® Extra Strength Gel Caplets
Excedrin® Extra Strength Tablets
Excedrin® Back & Body Caplets
Excedrin® Sinus Headache Caplets
Excedrin® Migraine Caplets
Excedrin® Migraine Gel Tablets
Excedrin® Migraine Tablets
Excedrin® Menstrual Complete Express Gel Caplets
Excedrin® PM Caplets
Excedrin® PM Express Gel Caplets
Excedrin® PM Tablets
Excedrin® Tension Headache Caplets
Excedrin® Tension Headache Express Gel Caplets
Excedrin® Tension Headache Gel Tablets

All lots of Gas-X® Prevention® products with expire dates of December 20, 2013 or earlier

All lots of NoDoz® products with expire dates of December 20, 2014 or earlier

For more information visit the Novartis website at http://www.novartis-otc.com/otc/index.html