Novartis is recalling specific lots of Bufferin, Excedrin, Gas-X and No-Doz because of manufacturing concerns, including the possibility they've been contaminated with opiate painkillers. Sunday, the Food and Drug Administration announced that the products have several potential issues, including broken or chipped pills and products that may have been mixed up with each other.
During a teleconference with news reporters, the FDA's Dr. Edward Cox noted what WebMD called a "slight but real risk" that prescription medications could adulterate the over-the-counter products.
In all, 1,645 lots of the OTC medications are being recalled. All of the products subject to this voluntary recall were made at the Novartis plant in Lincoln, Neb. The Novartis advisory, also released through the FDA, said that operations at the plant have been suspended temporarily "to accelerate maintenance and other improvement activities at the site."
The opioid drugs that may have adulterated the OTC products are manufactured at the plant for Endo Pharmaceuticals and marketed as Percocet, morphine, Endocet, Opana and Zydone, the FDA said.
The government agency recommends that people who take prescription painkillers look at their medications to make sure they're all the same size, shape and color that typically come in the prescription. In the unlikely event one is different, Cox said, they should not ingest it and should return it to the pharmacy.
The recalled Excedrin and No-Doz products have expiration dates of Dec. 20, 2014, or earlier, while the Bufferin and Gas-X Prevention products have expiration dates of Dec. 20, 2013, or earlier. The FDA calls it a "precautionary" measure and Novartis said that it "not aware of adverse events reported with the issues leading to the recall."
In a statement, Novartis said the potential problem was found when it conducted an internal product review after it got customer complaints. FDA inspection reports dated June 13 to July 8, 2011, say those complaints have been coming in "since at least 2009," according to WebMD.
The products were distributed across the United States, but not internationally. The Excedrin products being recalled include caplets, tablets, sinus medication, migraine medication, gel tablets and others. All have the December 2014 expiration dates. Bufferin products include extra strength, low-dose and regular strength tablets.
Consumers with questions can contact the Novartis Consumer Relationship Center at 1-888-477-2403 (Monday through Friday, 9 a.m. to 8 p.m. Eastern time) or go online at www.novartisOTC.com.
Novartis also announced that a one-time charge estimated at $120 million to cover the recall and improvement efforts will be taken in the fourth quarter of 2011 by Novartis Consumer Health Inc.