Novartis Consumer Health, Inc. is recalling some of its over-the-counter (OTC) drugs, the U.S. Food and Drug Administration (FDA) just announced. The OTC products were distributed nationwide to wholesalers and retailers.
Involved in the recall are all lots of select bottle packaging configurations of its 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. The products may contain stray tablets, capsules, or caplets from other Novartis products, or they may contain broken or chipped tablets.
Mixing different products in the same bottle could cause consumers to ingest the wrong product and receive either a higher or lower strength than intended or an unintended ingredient. The defect could also lead to overdose; interaction with other medications a consumer may be taking; or an allergic reaction, if the consumer is allergic to the unintended ingredient. To date, the firm is not aware of any injuries or incidents related to this recall.
Novartis Consumer Health Inc. said it is advising its distributors and customers of the problem 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.
Consumers in possession of the recalled product(s) should stop using the product(s) and contact the Novartis Consumer Relationship Center, toll-free, at 1.888.477.240, Monday through Friday, from 9:00 a.m. to 8:00 p.m. Eastern Time (ET) for information on how to return the recalled OTC drugs and receive a full refund. The firm also suggests consumers visit its website at www.novartisOTC.com.
Adverse events related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax: Online: www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or fax: 1-800-FDA-0178.
The Novartis Consumer Health Inc. Lincoln, Nebraska facility has suspended operations and shipments while the facility undergoes maintenance and other improvement activities. Novartis said it plans to gradually resume operations following implementation of planned improvements and in agreement with the FDA.