GlaxoSmithKline ($GSK) is the latest company to have to pull off the market a drug manufactured at Novartis' ($NVS) deeply troubled plant in Lincoln, NE.
GSK recalled nearly 400,000 bottles of its blood pressure drug DynaCirc CR on the chance that tablets of other products made on the same line may have gotten mixed into the packages. That was one of many problems the FDA cited the plant for in its 483 inspection report. GSK said there have been no complaints of mixed products or reports of adverse reactions.
Novartis has recalled loads of its own products for the same reason and Endo Pharmaceuticals ($ENDP) has said the same thing may have happened with some of its opiates. Endo has since lined up additional suppliers for its drugs and said Monday that any shortages should be temporary.
The plant was voluntarily closed Dec. 19 to address a multitude of problems that have led to several recalls of Novartis over-the-counter products, including the entire Excedrin line. According to the FDA 483 report, 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. Among others, there were reports of Excedrin Migraine tablets also containing Excedrin caplets and regular-strength aspirin in an Excedrin Migraine geltabs carton.
The report said that as of Dec. 12, there were 1,360 unresolved consumer complaints. Novartis has said quality control and patient safety is important and that it is working with the FDA to raise standards at the facility.
But that is not the only plant for which Novartis is facing FDA concerns. The company's Sandoz unit recently reported that production of some of its drugs at a plant in Boucherville, Quebec, Canada, was suspended because remediation efforts there required it to stop some production lines.
- read the Reuters story