Novartis Consumer Health, Inc. (NCH) announced this week that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiration dates of Dec. 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiration dates of Dec. 20, 2013 or earlier, in the United States.
These over-the-counter products were distributed nationwide to wholesalers and retailers.
NCH states the recall is a precautionary measure because the products in question “may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”
The recall states:
Mixing of different products in the same bottle could result in consumers taking the incorrect product, 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 states the company is not aware of any “adverse events” reported to be caused by the potential content mix-ups or damage before the recall was announced.
For the three-page list of products affected by this recall, go to the press release page – http://www.fda.gov/Safety/Recalls/ucm286240.htm – and click on the link to products (PDF document).
The recall also states that the Novartis Consumer Health Inc. Lincoln, Nebraska facility has voluntarily suspended operations and shipments, “to accelerate maintenance and other improvement activities at the site,” and that this recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Novartis Consumer Health Inc. also s 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,” the release states.
NCH also advises consumers who bought the product(s) being recalled to stop using them and 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 recalled product(s) and receive a full refund.
More detailed information is listed on the Novartis web site at www.novartisOTC.com (as of Jan. 9, 2012.)
Consumers also should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the recalled products.
Adverse experiences that may be related to the use of these products also may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by Fax:
Regular mail: use postage-paid FDA form 3500 available www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Or by Fax: 1-800-FDA-0178
Novartis Consumer Health Inc. states it plans to gradually resume operations at its Lincoln site, “following implementation of planned improvements and in agreement with the FDA.”
The Lincoln site apparently represents a small portion of the company’s production. The release states, “The Novartis Consumer Health Inc. Lincoln, NE facility produces a variety of products mainly for the U.S. market with annual sales value of less than 2 percent of Novartis Group sales.”
The release also states that there is no projected date for when the plant will resume full operations, and there currently is no estimate of the full financial impact of the recall and the cost of “improvements” at the facility.
However, the release also states that, “NCH will take a one-time charge currently estimated at $120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility.”
The recall also states: “The Novartis Group is fully committed to ensuring the quality, safety and integrity of its products.
“All Novartis Group companies have a clear commitment to patients and Health Authorities to ensure high quality standards for all our products and services. Novartis Group companies stand behind the safety and efficacy of their products, and are fully committed to maintaining high quality standards at all production sites in the U.S. and around the world.
“All Novartis Group products are subjected to strict manufacturing, testing and monitoring standards. Where they fall outside the standards, Novartis Group companies take actions to correct the issue and may recall products as a precaution.”
Posted Jan. 10, 2012
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