***Consumer alert RECALL***

 Recall

• Excedrin® and NoDoz® Alertness Aid products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X® Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States.
  
  
  

  • All lots of Bufferin® products with expiry 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 expiry 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

    • Excedrin® FAQ

      1. Why are you announcing a voluntary recall of Excedrin®?
         Novartis Consumer Health, working with the FDA, decided to issue a voluntary recall of all lots of select bottle sizes of Excedrin®, NoDoz® Alertness Aid, Bufferin® and Gas-X® Prevention® products in the United States because the products may contain stray tablets from other Novartis products or contain broken or chipped tablets. All lots of listed Excedrin® products with expiry dates of December 20, 2014 or earlier are included in this recall (see “view impacted product lots”).
      2. Is the Excedrin® currently in my medicine cabinet safe?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
      3. Should I return Excedrin® to the store?
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
         Information on the affected bottle sizes and related expiry dates is available at www.novartisOTC.com (as of January 9, 2012). 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.
      4. Have there been complaints related to patient safety surrounding Excedrin®?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
      5. Has Novartis acted on these consumer complaints?
         Novartis Consumer Health is taking pre-emptive actions to ensure our products meet the highest quality standards, including voluntarily suspending operations at the Novartis Consumer Health Lincoln facility as well as suspending shipments from the site.
      6. Did the U.S. Food and Drug Administration (FDA) order the recall?
         No. Novartis Consumer Health initiated this voluntary recall. These actions have been communicated to the FDA and we are working closely with the agency and will continue to do so throughout this process.
      7. Is it possible that other products will be recalled?
         All lots of NoDoz® Alertness Aid products with expiry dates of December 20, 2014 or earlier as well as Gas-X® Prevention® products and Bufferin® with expiry dates of December 20, 2013 or earlier, in the United States have been recalled. At this time, there are no plans in-place to recall any other Novartis Consumer Health products. However, we will take whatever steps are necessary to deliver on our commitment to meet the highest standards and will not sacrifice quality to meet short-term business results.
      8. Which products besides Excedrin® were recalled?
         All Bufferin®, Gas-X® Prevention® and NoDoz® Alertness Aid products will be recalled from consumers, retailers and wholesalers.
      9. I can’t find Excedrin® at my local retailer, what should I use in place of it?
         You should contact your physician or healthcare provider if you have any questions.
      10. What should I do if I have questions about Excedrin®?
          Consumers that have questions about the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).
      11. I just took Excedrin®. What should I do?
          Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. If you have any questions or are experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. Consumers should also report the adverse event to the Novartis Consumer Relationship Center at 888-477-2403.

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

    • GAS-X® FAQ

      1. Why are you announcing a voluntary recall of Gas-X® Prevention®?
         Novartis Consumer Health, working with the FDA, decided to issue a voluntary recall of all lots of select bottle sizes of Gas-X®, Excedrin®, NoDoz® Alertness Aid and Bufferin® Prevention® products in the United States because the products may contain stray tablets from other Novartis products or contain broken or chipped tablets. All lots of Gas-X® Prevention® products with expiry dates of December 20, 2013 or earlier are included in this recall.
      2. Is the Gas-X® Prevention® currently in my medicine cabinet safe?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
      3. Should I return Gas-X® Prevention® to the store?
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
      4. Have there been complaints related to patient safety surrounding Gas-X® Prevention®?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
      5. Has Novartis acted on these consumer complaints?
         Novartis Consumer Health is taking pre-emptive actions to ensure our products meet the highest quality standards, including voluntarily suspending operations at the Novartis Consumer Health Lincoln facility as well as suspending shipments from the site.
      6. Did the U.S. Food and Drug Administration (FDA) order the recall?
         No. Novartis Consumer Health initiated this voluntary recall. These actions have been communicated to the FDA and we are working closely with the agency and will continue to do so throughout this process.
      7. Is it possible that other products will be recalled?
         All lots of select bottle sizes of Excedrin® and No-Doz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® products with expiry dates of December 20, 2013 or earlier, in the United States have been recalled. At this time, there are no plans in place to recall any other Novartis Consumer Health products. However, we will take whatever steps are necessary to deliver on our commitment to meet the highest standards and will not sacrifice quality to meet short-term business results.
      8. Which products besides Gas-X® Prevention® were recalled?
         All lots of select bottle sizes of Excedrin® and No-Doz® and Bufferin® products will be recalled from consumers, retailers and wholesalers.
      9. I can’t find Gas-X® Prevention® at my local retailer, what should I use in place of it?
         You should contact your physician or healthcare provider if you have any questions.
      10. What should I do if I have questions about Gas-X® Prevention®?
          Consumers that have questions about the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).
      11. I just took Gas-X® Prevention®. What should I do?
          Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. If you have any questions or are experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. Consumers should also report the adverse event to the Novartis Consumer Relationship Center at 888-477-2403.

    • All lots of NoDoz® products with expiry dates of December 20, 2014 or earlier (except for 2 count and 4 count packages)

    • NoDoz® Alertness Aid FAQ

      1. Why are you announcing a voluntary recall of NoDoz® Alertness Aid?
         Novartis Consumer Health, working with the FDA, decided to issue a voluntary recall of all lots of select bottle sizes of NoDoz® Alertness Aid, Excedrin®, Bufferin® and Gas-X® Prevention® products in the United States because the products may contain stray tablets from other Novartis products or contain broken or chipped tablets. All lots of NoDoz® Alertness Aid products with expiry dates of December 20, 2014 or earlier (except for 2 count and 4 count packages) are included in this recall.
      2. Is the NoDoz® Alertness Aid currently in my medicine cabinet safe?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
      3. Should I return NoDoz® Alertness Aid to the store?
         Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.
         Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday
         9 a.m. to 8 p.m. Eastern Time for information on how to return the affected products and receive reimbursement.
      4. Have there been complaints related to patient safety surrounding NoDoz® Alertness Aid?
         Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. However, we believe that a comprehensive recall is in the best interest of consumers who trust and rely on our products.
      5. Has Novartis acted on these consumer complaints?
         Novartis Consumer Health is taking pre-emptive actions to ensure our products meet the highest quality standards, including voluntarily suspending operations at the Novartis Consumer Health Lincoln facility as well as suspending shipments from the site.
      6. Did the U.S. Food and Drug Administration (FDA) order the recall?
         No. Novartis Consumer Health initiated this voluntary recall. These actions have been communicated to the FDA and we are working closely with the agency and will continue to do so throughout this process.
      7. Is it possible that other products will be recalled?
         All lots of select bottle sizes of Excedrin® and products with expiry dates of December 20, 2014 or earlier as well as Gas-X® Prevention® and Bufferin® products with expiry dates of December 20, 2013 or earlier, in the United States have been recalled. At this time, there are no plans in place to recall any other Novartis Consumer Health products. However, we will take whatever steps are necessary to deliver on our commitment to meet the highest standards and will not sacrifice quality to meet short-term business results.
      8. Which products besides NoDoz® Alertness Aid were recalled?
         All lots of select bottle sizes of Excedrin®, Gas-X® Prevention® and Bufferin® products will be recalled from consumers, retailers and wholesalers.
      9. I can’t find NoDoz® Alertness Aid at my local retailer, what should I use in place of it?
         You should contact your physician or healthcare provider if you have any questions.
      10. What should I do if I have questions about NoDoz® Alertness Aid?
          Consumers that have questions about the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).
      11. I just took NoDoz® Alertness Aid. What should I do?
          Novartis Consumer Health is not aware of any adverse events reported with the issues leading to the recall. If you have any questions or are experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. Consumers should also report the adverse event to the Novartis Consumer Relationship Center at 888-477-2403.
    © 2012 Novartis Consumer Health, Inc.
    
    
     

Please go to the link below for more information!

http://www.novartis-otc.com/otc/index.html