Novartis Consumer Health Recalls Certain OTC Medications Due to Manufacturing Issues

January 11, 2012 8:16 PM

As a precautionary measure, Novartis Consumer Health, Inc (NCH) has initiated a voluntary recall of certain over-the-counter (OTC) medications manufactured at a Lincoln, NE, facility. This recall includes all lots of select bottle packaging configurations of the following medications:

• Excedrin® (expiration December 20, 2014, or earlier)
• NoDoz® (expiration December 20, 2014, or earlier)
• Bufferin® (expiration December 20, 2013, or earlier)
• Gas-X Prevention® (expiration December 20, 2013, or earlier)

NCH initiated the recall because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets, as indicated in a news release.

NCH is notifying distributors and customers to arrange for return of all recalled products. Consumers that have the recalled products should stop using them. Additional consumer information including details on the specific product lots recalled and instructions on returning affected medications for a refund are available on the Novartis Web site. NCH advised that consumers experiencing any problems with these medications should contact their health care provider. Related adverse events may be reported to the FDA MedWatch Adverse Event Reporting Program using the online form or by following the instructions for faxing or mailing a report on the FDA Web site.