Starting Jan. 8, Novartis Consumer Health (NCH) began voluntarily recalling Excedrin and NoDoz Alertness Aid products with expiration dates of Dec. 20, 2014, and earlier, and Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier from stores in the United States.
Switzerland-based Novartis manufactures medicines, vaccines, diagnostic tools and other products for both humans and animals. The companies under the Novartis Group umbrella employ approximately 121,000 full-time associates and operate in over 140 countries.
NCH has reported the recall to the Food and Drug Administration (FDA) and has taken this action as a precautionary measure because some of their products may contain stray tablets, capsules or caplets from other products. They may also contain broken or chipped tablets.
According to the FDA, “Mixing 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.
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.” So far, no adverse effects have been reported to NCH or to the FDA.
In addition to notifying its distributors and customers, Novartis has set up a website to help consumers with the recall: www.novartis-otc.com/otc. The site outlines the reasoning behind their actions, how to return products for a full refund and what to do if adverse effects are experienced.
The site also includes a link to a detailed list of all the variations, caplets, tablets and gel caplets, of the recalled products: Bufferin Extra Strength, Bufferin Low Dose, Bufferin Regular Strength, Excedrin Back & Body, Excedrin Extra Strength, Excedrin Migraine, Excedrin PM, Excedrin Sinus Headache, Excedrin Tension Headache, Gas-X Prevention and NoDoz Maximum Strength.
The Novartis website states, “A comprehensive recall was initiated as a precautionary measure due to potential product mix-ups and is not based upon adverse events reported in relation to the recalled products. We believe this voluntary action is in the best interest of consumers who trust and rely on our products. As this is a voluntary recall at the consumer level, NCH advises consumers who have purchased these recalled products to discontinue use and return them to NCH for a full refund.”
This recall comes with Novartis’ recent decision to temporarily suspend production at its plant in Lincoln, Neb. for “maintenance and other improvement activities,” according to The Associated Press.
NCH plans to gradually resume operations at that site, following such planned improvements and in agreement with the FDA. Consumers with any further inquiries can contact NCH at 1-888-477-2403 from Monday to Friday, 9 a.m. to 8 p.m.
In other recall news, the Lancaster New Era recently reported that metal tissue boxes from a Bed Bath & Beyond in Lancaster County were found to be contaminated with low levels of radioactive material.
There are six boxes in total affected in the area, four of which were recovered from the store, located at 2350 Lincoln Highway East, but the other two were sold in December, one on Dec. 9 and one on Dec. 19. State officials are hoping that the owners return those contaminated boxes.
A spokesperson from the Pennsylvania Department of Environmental Protection said that the boxes would not contaminate anything or hurt anyone but that the radiation was simply above the acceptable level.
Likewise, a Nuclear Regulatory Commission (NRC) spokesperson reported that there isn’t any health threat to consumers; however, they are advised to return the boxes.
The recall started earlier this month when NRC officials found low levels of cobalt-60, a radioactive material, in a shipment of metal boxes that were manufactured in India. It was first discovered in California, when several packages on their way to Bed Bath & Beyond set off radiation alarms at a truck scale. This latest shipment is the only one the NRC believes to be contaminated, containing 220 boxes.
Bed Bath & Beyond is recalling all of their Dual Ridge tissue holders, which were sold in stores in July, and giving full refunds to customers who return them, according to the New Era.
All boxes removed from stores were taken to a radioactive waste disposal facility.