Plant: Lincoln, NE
Because this Novartis plant mostly produced over-the-counter drugs for itself, most of the damage was self-inflicted. It hurts when your entire line of your popular Excedrin products must be pulled from shelves and your competitors fill the empty spaces. Novartis also had to recall NoDoz, Bufferin and Gas-X Prevention products. The move has led to shortages of pet medications and even of Maalox in Canada.
But the plant also produced drugs for outside customers, some of which had to recall products, like Endo Pharmaceuticals ($ENDP), which had painkillers produced there. GlaxoSmithKline ($GSK) recalled nearly 395,000 bottles of its DynaCirc CR blood pressure drug over fears that other tablets made at the plant might have been mixed into the packages.
This is another case where no warning letter was issued, but the 483 inspection reports are on file and they detail a very long list of problems. The reports say the plant was lax about maintenance, short on staff and training, and complacent about some aspects of quality control that on many occasions led to the wrong drug showing up in containers.
The reports say that as of Dec. 12, there were 1,360 unresolved consumer complaints, 1,332 major and 31 critical, and the backlog had been more than 1,000 since Aug. 30. The complaints included "foreign products in container, suspected tampering, foreign object, missing label, discolored product, partial tablet, chipped/cracked and crumbled product." There were so many complaints Novartis brought in consultants to help review them.
The company has set aside $120 million to address the issues.