With the Food and Drug Administration warning Monday of the potential danger, Novartis AG has voluntarily recalled batches of over-the-counter drugs — Excedrin, Bufferin, No-Doz and Gas-X — for fear they may contains bits of prescription pain killers.
The FDA held a press conference on the recall, which involves 1,645 lots of the OTC drugs.
The problem stems from a plant in Lincoln, Neb., that was closed last month. In addition to making Novartis products such as Exedrin, that plant also manufactured prescription drugs such as Percodet and morphine tablets for Endo Phamaceuticals, according to The Wall Street Journal and other press reports.
A press release from Parsippany, N.J., based Novartis Consumer Health Inc. (NCH) said, “NCH 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 tablets.”
http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml
The recall involves Excedrin and NoDoz products with expirarion dates of Dec. 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013 or earlier, in the United States.
” The Novartis Consumer Health Inc. Lincoln, Neb., facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site,” the drug maker said. “This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).”
http://www.fda.gov/Safety/Recalls/ucm286240.htm
According to NCH, “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. 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.”
However, NCH said that it is not aware of adverse events reported with the issues leading to the recall.
The recalled OTC products were distributed nationwide to wholesalers and retailers. NCH is notifying its distributors and customers and is arranging for return of all recalled products.
“We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network,” Swiss Novartis CEO Joseph Jimenez said in a statement. “The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines.”
NCH said that it is is recalling these products as a precaution due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.
NCH plans to gradually resume operations at its Lincoln site following implementation of planned improvements and in agreement with the FDA. That plant produces a variety of products mainly for the U.S. market with annual sales value of less than 2 percent of Novartis Group sales.
At this stage, the drug maker said that it’s not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at $120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln facility.
Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.
Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
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