Novartis/Sandoz

Basel, Switzerland
4 Class I recalls

Though it's been out of the Class I recall news lately, Novartis ($NVS) and subsidiary Sandoz took back products four times between 2012 and 2013, tying for fourth on this list of top pharma recallers.

Generics maker Sandoz issued three of the recalls, one in 2012 and two in 2013. In 2012, the company found a packaging flaw for the generic oral contraceptive Introvale and recalled 10 lots. The next year, the unit took back two lots of methotrexate sodium after a report of particulate in vials and one lot of Estarylla after a consumer found a placebo pill in a row of active tablets.

Also in 2012, Novartis' consumer health division issued a wide-ranging recall on OTC products Excedrin, NoDoz, Bufferin and Gas-X. As precautionary measure against the possibility of stray tablets from other Novartis products being in the bottles, the company took back all lots of selected packaging configurations. However, those problems won't be Novartis' going forward. As part of its multibillion dollar asset swap with GlaxoSmithKline ($GSK) last year, the two created a joint venture for their consumer healthcare operations that is being run by GSK.

Lately, however, Novartis has largely avoided manufacturing woes as it hasn't posted a Class I recall since July 2013. In an emailed statement, Novartis spokesperson Elizabeth Power said the company completed 33 health authority inspections in the first quarter of 2015, with all rated "good" or "acceptable."

"It is our obligation and commitment as a company to consistently deliver the quality patients deserve and expect, and to ensure the integrity, safety and efficacy of our products," she said. "We are constantly monitoring the quality of our production around the world to ensure that all Group company sites and operational units operate to a single quality standard."

-- Eric Sagonowsky (email | Twitter)

For more:
Novartis' OTC recall is tied to a contractor this time
Novartis can't get past foul-ups at consumer plant; recalls 4.4 million bottles of Maalox
FDA report shows deep problems at closed Novartis Consumer Health plant

Novartis/Sandoz
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