Chipped and broken pills, as well as the possibility of medication mix-ups has led Novartis to issue a recall for 1,645 lots of Excedrin, Bufferin, NoDoz and Gas-X.
In addition to pills being broken and cracked, the FDA says there is a possibility that powerful prescription-strength opiates, like Percocet and morphine, may have infiltrated the over-the-counter Novartis drugs. Although there have been no adverse events or injuries reported by consumers in connection with the recalled drugs, this could pose a serious risk for consumers.
The recall and warning came after consumers began reporting that pills in bottles of Excedrin, Bufferin, NoDoz and Gas-X were chipped and broken. This could mean that the pills contain an improper dosage or that fragments or whole pills from other products ended up in the wrong packages.
The problems stem from a manufacturing plant in Lincoln, Nebraska, that handles both Novartis OTC drugs, like Excedrin and Bufferin, and also produces painkillers for the company’s Endo Pharmaceuticals subsidiary.
The FDA is concerned that the Endo Pharmaceuticals line of opiates uses the same building. Particularly, the products are manufactured on the same line as Gas-X.
The agency is warning people to be on the lookout for the potential for pills that look different from others in the same bottle. According to Endo, there have been three such incidents since 2009, all of which were found by pharmacists.
Endo pharmaceuticals painkillers affected by the FDA warning include Opana, Opana ER, oxymorphone hydrochloride, Percocet, Percodan, Endocet, Endodan, morphine sulfate and Zydone. The FDA says the risk of finding the wrong pill in the wrong bottle is low and determined that no recall was required of those products.
However, Novartis did decide to recall Excedrin, Bufferin, NoDoz and Gas-X because of the damaged pills and risk that those drugs could be mixed together in packages. The recall affects Excedrin and NoDoz products with an expiration date of December 20, 2014 or earlier, and Bufferin and Gas-X products with an expiration date of December 20, 2013 or earlier.
The company said that its Nebraska plant is implementing improvements approved by the FDA to prevent a recurrence of the problem and will gradually resume operations as those improvements are put into place.
Consumers with questions or who have products that have been recalled can contact Novartis at (888) 477-2403 or visit the website at www.novartisOTC.com for information on how to return the products and receive a full refund.