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Anne Law

Novartis recalls, plant troubles reminiscent of J&J bungles

by Anne Law | Dun & Bradstreet Editor

January 10, 2012 | 2 Comments »

The plant shutdown and product recalls announced by Novartis this week bring to mind the early days of the great Johnson & Johnson Tylenol debacle, and makes one wonder whether it will become a similar drawn-out saga.

Novartis’ manufacturing troubles have been escalating in recent months, culminating in a recall announced this Sunday of 1,645 lots of over-the-counter painkillers Excedrin and Bufferin, as well as the company’s NoDoz and Gas-X remedies.

The recalls are linked to the possible presence of stray tablets of other Novartis Consumer Health products, as well as due to possible broken or chipped tablets, within the recalled packages.

The most concerning mix-up is the possible presence of prescription painkillers (including Opana and Percocet, which are made for Endo Pharmaceuticals on a contract basis at the plant) in Gas-X packages.

The recalled products were manufactured at Novartis’ Lincoln, Nebraska, plant, which was shut down in December to fix production line practices that FDA inspectors indicate as potential causes for the medication mix-ups. The plant has been under fire by the FDA since last summer, with regulators blasting Novartis for failing to act on reports of tablet mix-ups going back to 2009.

None of Endo’s painkillers are being recalled at this time (as few incidents have been reported with these products, which are screened by pharmacists prior to consumer use), but Endo has stated that the Novartis plant shutdown will likely create a shortage of the medications.

Novartis is downplaying the impact of these recent troubles, stating that it will be able to make up for potential shortages with existing inventories and by transferring the recalled product lines to other manufacturing locations until the Nebraska plant is restarted.

But the company was already facing regulatory scrutiny at several other manufacturing facilities, including those of generic prescription drug unit Sandoz, and there could be more plant shutdowns and product recalls in Novartis’ near future if the FDA follows its recent habit of thoroughly investigating all facilities of troubled manufacturers.

J&J is the most shining example: The company has had a landslide of recalls and plant inspection complications — many of which are still being resolved — since its manufacturing difficulties were first uncovered back in 2009.

Whether Novartis can curb its problems before they take on a similar snowball effect, and save face to consumers who depend on its products in the meantime, remains to be seen.

As a Rescue group for Retired Race Greyhounds. I am concerned about their Canine products. Do you have any info on this? According to my Vet, his Rep from Novartis told him that it’s a warehouse shutdown only. I’m worried because we depend so much on their Heartworm meds and other drugs ie. Deramaxx. If you would check this out as well, I would greatly appreciate it.

Mona Moore – Regap of Illinois, Inc.

The Lincoln, Nebraska, plant has suspended production for an unknown amount of time. It is possible that some animal health products could go into short supply as a result, but at this time the FDA has not added any Novartis products to its list of current veterinary product shortages (http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm267669.htm).

No human medications from the Novartis site are listed on the FDA shortage list at this time either, but that could change if the plant is not restarted promptly.

Here is an article from Mary Straus of the Whole Dog Journal that provides some alternative veterinary medicine ideas should an actual shortage occur: http://www.whole-dog-journal.com/blog/Novartis-Canine-Heartworm-Medication-Shortages-20448-1.html

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