The U.S. unit of Novartis AG on Sunday issued a nationwide voluntary 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 Dec. 20, 2014, or earlier, and for Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier.