Novartis recall hints at regulatory snowball

Uh-oh. Novartis ($NVS) is recalling some OTC drugs made at a Nebraska plant that was recently shut down for maintenance and upgrades. The voluntary recall is one thing. But the recall's timing, so close to that of the voluntary plant shutdown, which occurred so close to a warning letter citing three of the drugmaker's other plants in North America (in Colorado, North Carolina and Canada), may imply the kind of systemic trouble that consent decrees are made of.

That's not to say a consent decree is imminent. There are examples in which the poor-inspection/plant-shutdown/product-recall scenario is played out sans consent decree, or even warning letter, for that matter. The recent Ben Venue case comes immediately to mind.

But there are notable examples in which the FDA has pulled the court card, too: Ranbaxy, Johnson & Johnson ($JNJ)/McNeil and Genzyme. In Ranbaxy's case, a product import ban substitutes for the plant shutdown.

In an announcement made Sunday, Novartis said its consumer health unit (NCH) is conducting the recall while Novartis Group "strengthens quality standards across all manufacturing sites." Recalled products are OTC heavyweights Excedrin, Bufferin and NoDoz, in addition to Gas-X.

"Hundreds of complaints" of broken and chipped pills are behind the recall, The Associated Press reports, as well as "inconsistent bottle packaging that could cause pills to be mixed up." Candidates for mix-ups with the recalled drugs are opioids Percocet, Endocet, Opana and Zydone, which are sold by Endo Pharmaceuticals ($ENDP), AP 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," Novartis said in the announcement.

AP reports the recall encompasses a combined 1,645 lots.

Novartis didn't state a time frame in its Nebraska remediation announcement. That's probably wise. The typical follow-on step in the poor-inspection/plant-shutdown/product-recall scenario is an announcement extending the remediation timeline.

- read the Novartis announcement
- here's the AP story
- see the FDA advisory

Related Articles:
Novartis adds OTC drug plant to GMP fix list
FDA notes lack of Novartis exec response in 3-site warning
Daiichi grimaces at Ranbaxy, FDA consent decree
Ben Venue lengthens remediation timeline
McNeil's consent decree terms could have been worse

Suggested Articles

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

Just weeks after selling the sterile manufacturing assets of its Kyowa operation in Japan, it has unloaded the rest of its Kyowa drugmaking operation.

India’s Aurobindo, which has yet to close its $1 billion deal to buy 300 Sandoz products in the U.S., continues to rack up FDA issues.