If you take Excedrin, NoDoz, Bufferin or Gas-X Prevention or if you know you have any of these over-the-counter medications in your home, the U.S. Food and Drug Administration is advising that you dispose of these products as soon as possible.
Drug manufacturer Novartis Consumer Health, Inc. said recently that it is voluntarily recalling bottles 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.
Excedrin is most often used for headaches, including migraines, and Bufferin, which contains aspirin, is a painkiller. NoDoz is an alertness aid caffeine caplet.
Novartis said it is taking this action as a precautionary measure. According to the FDA, the agency received reports of chipped and broken pills and inconsistent bottle packaging clearance practices at the company’s Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or capsules.
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. Novartis said it is currently 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 said it is notifying its distributors and customers and is arranging for return of all recalled products.
Consumers that have the product or products being recalled should stop using the medication and contact the Novartis Consumer Relationship Center at 1-888-477-2403 – available Monday through Friday, 9 a.m. to 8 p.m. EST – for information on how to return the affected products and receive a full refund.
For more detailed information, consumers can visit www.novartisOTC.com. 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.
Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online at
www.fda.gov/medwatch/report.htm or by fax at 1-800-FDA-0178.
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