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Novartis issued a recall on Sunday for a number of its over-the-counter drugs, including Excedrin and Bufferin, due to mislabeled and broken pills during manufacturing.
The voluntary recall was announced Sunday by the Switzerland-based pharmaceutical company of Excedrin and NoDoz with expirations dates of Dec. 20, 2014, and Bufferin and Gas-X Prevention with a Dec. 20, 2013, expiration though no adverse health effects were reported.
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"(Novartis) is taking this action as a precautionary measure, because the products may contain stray tablets, capsules or caplets from other Novartis products, or contain broken or chipped pills," the company said.
The recall was coordinated with the U.S. Food and Drug Administration when reports emerged of "broken gelcaps, chipped tablets and inconsistent bottle packaging." The complaints became evident after an internal review of the products and reports from consumers that the pills were mislabeled and were indeed stray pills.
Edward Cox of the FDA's Center for Drug Evaluation and Research said a manufacturing plant in Lincoln, Neb., which also makes medications for Endo Pharmaceuticals like Opana and Percocet, was the cause of the problem.
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"it's possible that tablets from one product may have been retained in the packaging machinery, and then may have carried over into the packaging," Cox said in a statement Monday. "This could result in an incorrect pill of one medicine ending up in the bottle of another product."
Novartis said the recall is a "precautionary measure" and consumers should "either destroy or return" products that match those described in the recall.
A spokesperson for Novartis said the voluntary recall is a precaution so that people who may be allergic to the mistaken stray pills do not suffer any serious side effects from taking the mislabeled medication.
According to a press release from Novartis, the recall and upgrades will cost the company about $120 million, to be charged to the fourth quarter of 2011.
It is unclear how many pills are affected by the recall.
Consumers with questions are encouraged to contact the Novartis Consumer Relationship Center at 1-888-477-2403. Consumers can fill out a form for a refund at Novartis' Web site and will receive $2 for shipping costs when product is returned by mail for a full refund.
Here is a full list of the products being recalled by Novartis from the company Web site.
All lots of the following Excedrin® products have been recalled with expiry dates of December 20, 2014, or earlier
Excedrin® Extra Strength Caplets
