Missouriwatcher
Editor, Senior Moderator
Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall Of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps
January 8, 2012 –Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® 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. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
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. NCH is not aware of adverse events reported with the issues leading to the recall.
These over-the-counter products were distributed nationwide to wholesalers and retailers.
Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them...
http://www.fda.gov/Safety/Recalls/ucm286240.htm
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
http://www.novartis-otc.com/otc/index.html
January 8, 2012 –Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® 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. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
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. NCH is not aware of adverse events reported with the issues leading to the recall.
These over-the-counter products were distributed nationwide to wholesalers and retailers.
Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them...
http://www.fda.gov/Safety/Recalls/ucm286240.htm
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
http://www.novartis-otc.com/otc/index.html
