Generic drugmaker Sandoz is recalling two lots of an injectable drug, making yet another manufacturing problem for its parent, Novartis ($NVS).
The company and the FDA said yesterday that Sandoz is voluntarily recalling the methotrexate sodium, a drug used to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The recall was ordered after particulates were found in retained samples of the preservative-free injectable drug. There have been no adverse reactions reported, and the company made clear that the particulates are not associated with microbial contamination. It warned, though, that if particulates are injected, there is always the chance of an embolism. The two lots were distributed in the U.S. and Poland. Sandoz is the second largest generic drugmaker in the world.
Novartis has for several years now been facing down a number of manufacturing problems. In 2011, the FDA sent Sandoz a warning letter laying out issues it had with plants in Broomfield, CO; Wilson, NC; and Boucherville, Quebec. Late last year, the FDA removed the Broomfield plant from its warning letter watch list, and Novartis CEO Joseph Jimenez has indicated that the other two are making progress toward returning to the good graces of the U.S. agency.
Simultaneously, the Swiss drugmaker has been dealing with myriad issues at its consumer health plant in Lincoln, NE, which have been a drag on earnings and a particular sore point for Jimenez. Last month, the company said that it had decided to cut the workforce there by 40%, or about 300 workers, in the next two years and narrow its manufacturing focus. The company will now make just solids and powders, primarily for the popular veterinary product Sentinel, as well as Excedrin and Theraflu.
- here's the recall alert
Related Articles:
FDA confirms Novartis plant, renewing CEO's confidence
Novartis rewards Swiss OTC plant, takes ax to Lincoln
Novartis' Q2 sales hit after Excedrin production woes
Novartis remediation drags on longer than expected
Novartis plant disruptions affect pet treatments