The Associated Press reported a warning from the FDA about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X made at a Novartis manufacturing plant. 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 (the three page list of affected products can be found here).
The problem stems from major manufacturing problems at a Lincoln, Neb., facility which triggered a sweeping recall of the company’s over-the-counter drugs on Sunday. The company has received complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. Consumers should not use the products and can contact the company for a refund.
FDA officials warned Monday that some of Novartis’ over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone. The full FDA release can be read here.
Novartis plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The Novartis Nebraska facility produces a variety of products mainly for the US market with annual sales value of less than 2% of Novartis Group sales. At this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. Novartis will take a one-time charge currently estimated at USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln facility.
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