Sandoz recalls 1M units of generic Zyrtec made in India

Novartis CEO Joe Jimenez

Novartis CEO Joe Jimenez took a swipe at Sandoz's Indian competitors last year, suggesting there would be fallout in the generics market as smaller players were unable to "build quality into their systems" to meet rising regulatory demands. Now a Sandoz plant in India is having its own issues, recalling more than 1 million packages of a generic of the number one selling allergy pill Zyrtec.

According to the most recent FDA Enforcement report, Sandoz is recalling 1,023,430 blisterpacks of cetirizine HCl chewable tablets. It said the 9 lots were recalled after they were found to be out of specification for impurities when tested at 21 months. The recall says the product was made at a Sandoz plant in Mumbai.

There is no question that many Indian drugmakers, including the largest generics companies there, have stumbled over quality manufacturing standards. The FDA has banned plants operated by Ranbaxy Laboratories and its new parent Sun Pharmaceuticals, Wockhardt and others because of data integrity and other manufacturing concerns.

But Novartis ($NVS) has faced its own manufacturing missteps, a fact that Jimenez acknowledged when talking about the competition. He just suggested the Big Pharma companies like Sandoz were in a better place to deal with them. For several years, quality issues and recalls dogged Novartis consumer health operation, most of that was tied to the Novartis Consumer Health manufacturing facility in Lincoln, NE. Quality issues in manufacturing became such a sore point for Jimenez that in 2012, he issued "quality first" manifesto of sorts.

The problems at the Lincoln plant are actually no longer a worry for the CEO after Novartis last year ceded control of its consumer health operations to a joint venture controlled by GlaxoSmithKline ($GSK) in their multibillion asset swap.

- here's the recall notice