Pill mixups at 'Excedrin' plant a problem for many years

Local 6 obtains FDA inspection report

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The makers of popular headache medicine Excedrin apparently knew about pill mix-up problems at a Lincoln, Nebraska facility for years before they issued a mass recall on their products.

Excedrin and other popular over the counter medications were recalled in January, leading to a nationwide shortage.

Some consumers turned to online auction sites like Ebay to get their hands on Excedrin, where the pain reliever is selling for upwards of $100 a bottle.

Local 6 obtained a Food and Drug Administration inspection report  of the Novartis Consumer Health facility that manufactures Excedrin.  

Part of it states, "Your firm has been aware of multiple mixed product complaints since at least 2009, yet a complete market correction (due to this problem) was not executed until 1/18/12, which occurred during the course of this FDA inspection."

Those mix-ups may have included over the counter drugs mixed with schedule II narcotics that are only available by prescription.

The report details problems not only with Excedrin and it's entire product family but also Bufferin, NoDoz, GasX, Prevacid and the prescription painkillers Endocet, Percocet, Morphine Sulfate ER and Opana.

The problems include "foreign product, foreign object, suspected tampering, chipped/cracked/crumbled tablets, broken/missing seal, etc."

At the plant's product packaging line where the prescription drugs are manufactured, products like Excedrin and Gas-X were found. The FDA reprimanded the company's internal investigation by stating, "this investigation fails to address how '28 assorted tablets' … could have entered a room dedicated to packaging other products."

The report goes on to detail how the company blamed the problem on ‘human error' but did not address which employee's may have been responsible.

A spokesperson for Novartis would not state why the company did not previously issue any widespread recalls of their products, and only issued a statement that reiterated that they did the recent recall with the guidance of the FDA.

"The issues that led to our decision to issue the voluntary recall in January came to light through several quality and regulatory processes that gather consumer feedback on a regular basis, as well as internal reviews and FDA inspections," said Julie Masow, director of external communications and media relations for Novartis Corporation.

The FDA report also reprimands Novartis for its handling of consumer complaints about their products, stating: "As of 12/12/11 your firm is overdue(untimely) with adequately conducting approximately 1,360 investigations you have received from consumer complaints (1332 are major, 31 are critical). This backlog of overdue complaints has been over 1,000 in number since at least 8/30/11."

Local 6 placed a Freedom Of Information Act request for all investigations and correspondence at the plant over a two year period, but only information that was considered ‘closed' was made available.

Novartis did not say if any upgrades or improvements were made to their facility since the recall but did announce last week that they are making Excedrin again at their plant.

"Upon successful validation, we expect to begin shipping a limited portfolio of products from Lincoln in the fourth quarter. In addition, we have engaged third-party manufacturers to bolster supply of select products, which will help meet demands of our customers and consumers. These third-party manufacturers have already started production, and shipment of products is expected to begin in the fourth quarter," said Masow.

She also made clear that the company does not want consumers using any of the medications affected by the recall.

"We'd appreciate it if you could advise your viewers not to use the recalled products and return them to Novartis Consumer Health for a full refund. They can contact the Novartis Consumer Relationship Center at 1-888-477-2403 or email otc.recall@novartis.com for information on how to return the affected products and receive reimbursement," she said.

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