Manufacturer’s Errors Prompt Drug Recall and Shut-down of Production Plant

Defective Medications

According to an LA Times article, a nationwide recall of Novartis’s over-the-counter medications, Excedrin, NoDoz, Bufferin and Gas-X, was issued January 8. The recall follows concerns that certain bottled versions of these drugs may contain other Novartis medicines. Powerful prescription drugs including those manufactured for Endo Pharmaceuticals, such as Zydone, Endocet, Percocet and Opana, are among the drugs that may have been mixed in with the over-the-counter medications. The Swiss pharmaceutical company’s Lincoln, Nebraska facility is at the center of manufacturing the defective medications.

Even though certain tablets are simply chipped or broken, the mix-up of different drugs could be far more serious. It could cause unintentional overdoses or allergic reactions for consumers who unwittingly take medications for which they have no prescription. Additionally, the interaction of different medications could also cause unwanted side effects and symptoms, with consumers unaware of the cause and at risk for serious injury.

Products Affected

The comprehensive recall only affects Novartis products produced in the United States and includes all bottle sizes with expiration dates of 12/20/2014 or earlier.Defective Medications For Excedrin®, NoDoz® Alertness Aid products, Bufferin and Gas-X Prevention medicines with expiration dates of 12/20/2013 or earlier may also be affected. Complete details about the recall as well as the lots affected are listed on the Novartis website.

Even though the U.S. Food and Drug Administration assures consumers that the risk of any serious event is unlikely, the agency advises users to discontinue the affected products, contact the Novartis Consumer Relationship Center and return the medicines for a full refund. Novartis has reported no adverse events leading up to the recall, however the FDA urges consumers who may experience any adverse events to consult their healthcare providers or doctors as soon as possible.

Not the First Time for Novartis

The Novartis plant also came under fire last year when FDA inspectors alleged multiple faults in the production line practices. The FDA reported that Novartis “failed to adequately investigate” some 166 complaints of pill mix-ups as far back as 2009. Citing examples such as the errors involving Excedrin Migraine tablets, caplets and gel caps, the FDA announced dissatisfaction at the half-hearted investigation mounted by Novartis.

Despite the problems with over-the-counter medications, Endo prescription medicines were not affected by the recall because few problems were reported with those products. Endo predicts a shortage of the medications, however, because the entire Nebraska facility, including operations that manufacture the prescription medications, is closed. According to Chief Operating Officer Julie McHugh, the company has asked doctors to refrain from writing new prescriptions for these drugs to ensure an adequate supply for those already taking the medications.

The Novartis group assures the public that the company remains committed to insuring the safety, quality and integrity of products, but with the recent manufacturing blunders upsetting the company, it becomes difficult to trust the manufacturer’s promises.

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If you or someone you care about was affected by medication mistakes by Novartis or any other drug manufacturer, contact our experienced attorneys for a free consultation. The time allowed by law for filing a claim is limited, so it is important that you contact us soon.

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