(Reuters) - The U.S. unit of Novartis AG on Sunday issued a nationwide recall of certain bottled versions of Excedrin and Bufferin, and two other products, because they may contain stray, broken or chipped tablets from other Novartis products.
Novartis Consumer Health said the recall, which also applies to bottled versions of NoDoz and Gas-X Prevention, is a precautionary measure.
Novartis said mixing of different products in the same bottle could result in taking an incorrect product or receiving a higher or lower strength than intended or receiving an unintended ingredient, which could potentially result in overdose or an allergic reaction.
Novartis said it has voluntarily suspended operations and shipments from its Lincoln, Nebraska, facility to rectify the problems at the site. Novartis said its Consumer Health unit will take a one-time charge currently estimated at $120 million in the fourth quarter relating to the recalls and improvements at the facility.
Novartis said the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The recall is for bottled packages of Excedrin and NoDoz with expiration dates of December 20, 2014, or earlier, and for Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013, or earlier.
Novartis said there had not been any adverse events reported and that the U.S. Food and Drug Administration (FDA) was aware of the recall.
The products are being recalled due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.
The company said it has notified its distributors and retailers. Consumers can find more information on the website ww.novartis-otc.com/otc/index.html.