Bufferin, Excedrin, NoDoz, Gas-X Recalled
Pill Mixup: Bottles May Contain Stray Pills, Prescription Painkillers
Jan. 9, 2012 -- Bufferin, Excedrin, Gas-X, and NoDoz products have been recalled because they may be mixed with one another, contain broken tablets, or contain prescription painkillers.
Drugmaker Novartis is voluntarily recalling 1,645 lots of the four products. All four of the recalled products -- as well as nine prescription opiate painkillers including Percocet and morphine -- were made at the same plant in Lincoln, Neb. The opiate painkillers are made at the Novartis plant for Endo Pharmaceuticals.
At a news teleconference, Edward Cox, MD, director of the FDA's office of antiviral products, said there was a slight but real risk that opiate prescription drugs could end up in the over-the-counter products.
"There is a potential risk that it could happen," Cox said. "That is the reason for the consumer-level recall, because there is the potential for a product mix-up there."
Packages of each of the brands may contain tablets, caplets, or capsules of other products. Some of the pills may be broken or chipped.
All Bufferin products with expiration dates of Dec. 20, 2013, or earlier have been recalled. Brand names include Bufferin Extra Strength Tablets, Bufferin Low Dose Tablets, and Bufferin Regular Strength Tablets.
All Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier have been recalled.
The following Excedrin products with expiration dates of Dec. 20, 2014, have been recalled:
- Excedrin Extra Strength Caplets
- Excedrin Extra Strength Express Gel Caplets
- Excedrin Extra Strength Gel Caplets
- Excedrin Extra Strength Tablets
- Excedrin Back & Body Caplets
- Excedrin Sinus Headache Caplets
- Excedrin Migraine Caplets
- Excedrin Migraine Gel Tablets
- Excedrin Migraine Tablets
- Excedrin Menstrual Complete Express Gel Caplets
- Excedrin PM Caplets
- Excedrin PM Express Gel Caplets
- Excedrin PM Tablets
- Excedrin Tension Headache Caplets
- Excedrin Tension Headache Express Gel Caplets
- Excedrin Tension Headache Gel Tablets
The recalled products were distributed throughout the United States, but not internationally.
There have been no reports of illness or injury from the products.
"Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient," Novartis warns. "This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient."
Consumers who have the recalled products should stop using them and contact Novartis (888-477-2403 or novartisOTC.com) for information on returning them for a refund.
People who may have had adverse events related to the products should report them to the FDA's MedWatch program (www.fda.gov/medwatch/report.htm).
FDA: Plant Problems Date to 'at Least 2009'
In a statement, Novartis says it confirmed the problem during an internal product review following customer complaints. According to an FDA inspection report dated June 13 to July 8, 2011, those complaints have been coming in since "since at least 2009."