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Over-The-Counter Medications Recalled Because of Accidental Inclusion of Prescription Pharmaceuticals

Novartis International AG, the second-most lucrative pharmaceutical company in the world, has just recalled a number of over-the-counter medications because packages of pills may have accidentally included doses of powerful prescription medications.

Although the U.S. Food and Drug Administration is not recalling all containers of these medications because they may be otherwise medically necessary, the FDA has released a public warning, cautioning consumers about the potential mix-up.

According to reports by the Associated Press, the problem arose at an American Novartis production facility, which has subsequently been shut down. In 2010, Novartis International AG, a major manufacturer of generic prescription drugs, recorded sales of $46.806 billion. A number of the prescription drugs inadvertently included in the over-the-counter medications were opioids (drugs used in the treatment and management of pain) that are otherwise sold under the labels Percocet, Endocet, Opana, and Zydone. Pieces of the prescription drugs made their way into containers of the over-the-counter remedies, which is what caused the concern and the resulting recall.

This past Sunday, Novartis AG issued a nationwide retraction of certain bottled versions of Excedrin (a headache pain-reliever), Bufferin (an anti-inflammatory medication for minor aches and pains), Gas-X (a pill intended to relieve pain caused by excess gas in the stomach), and No-Doz (a caffeine stimulant), saying that they may contain stray, broken, or chipped parts of prescription tablets of drugs which were manufactured at the same plant.

This situation is a prime example of Illinois product liability law; product liability is an area of Chicago personal injury law that focuses on dangerous and defective products. Although no injuries have yet been reported as a result of the mistake, because Novartis AG’s negligence led to the prescription medications’ inclusion in over-the-counter products, Novartis could be liable for damages if injuries do arise.

Said the FDA’s recall report, mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength pain-reliever drug than otherwise intended, or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a customer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

Although the Consumer Health division of Novartis has publicly stated that the recall is a precautionary measure, the tainted over-the-counter packages were distributed to wholesale and retail stores across the country. With such widespread dissemination, the risk to consumers is enormous.

Novartis AG plans to notify distributers and customers, and is urging customers to return potentially hazardous packages. Our Chicago personal injury lawyers have handled numerous cases in which customers have been injured by dangerous, defective, or diseased products. If you or a loved one have suffered as a result of using an unsafe product, contact an attorney to be apprised of your rights under the law.

This recall includes packages of Excedrin and No Doz with expiration dates of Dec. 20, 2014, or earlier, and for Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier. Specifically recalled are:

Bufferin Extra Strength Tablet, Bufferin Low Dose Tablets, Bufferin Regular Strength Tablets, Excedrin Back & Body Caplets, Excedrin Extra Strength Caplets, Excedrin Extra Strength Express Gel Caps, Excedrin Extra Strength Gel Tablets, Excedrin Extra Strength Tablets, Excedrin Migraine Express Gel Caplets, Excedrin Migraine Caplets, Excedrin Migraine Gel Tablets, Excedrin Migraine Tablets, Excedrin PM Caplets, Excedrin PM Express Gel Caplet, Excedrin PM Tablets, Excedrin Sinus Headache Caplets, Excedrin Tension Headache Caplets, Excedrin Tension Headache Express Gel Caplets, Excedrin Tension Headache Gel Tablets, Gas-X Prevention Caplets, No Doz Maximum Strength Caplets