Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown

Consumer complaints of bottles containing mixed-up or damaged tablets and capsules and an extended FDA 483 focused on complaint handling at a Lincoln, Nebraska facility where they were made prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at the plant.

In early January, Novartis Consumer Healthcare initiated a consumer-level recall involving lots of Excedrin, Bufferin, NoDoz and Gas-X Prevention tabs and caps manufactured at the Lincoln plant.  The company also announced a “voluntary suspension” of the plant’s operations and shipment “to accelerate maintenance and other improvement activities at the site.”

Novartis emphasized in its release that it is not aware of any “related adverse events reported with the issues leading to the recall.”  US Consumers are asked to either destroy or return unused product identified in the recall to Novartis Consumer Health.

[The story, including an analysis of and links to the Lincoln 483 and other related FDA enforcement information, continues for subscribers here.  Nonsubscribers can purchase the story for $195 by contacting Jonathan Trethowan (  For subscription/license information, click here.]

Also see related IPQ stories:

Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan

Key Pillars of a Quality Culture are Management Commitment, Sharing Inspection Results and Early QbD, Industry Execs Affirm