Danish drugmaker Novo Nordisk ($NVO) is recalling 33 batches of insulin pens in the U.K. because of a manufacturing issue that led to a very small number of them having a very large disparity in their insulin fills.
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) issued the drug alert Friday for the NovoMix 30 FlexPen and Penfill cartridge, saying the drugmaker estimated only 0.14% of the 3.3 million pens and refill cartridges it sold in Europe might be affected. Still, that would be 4,620 units. And according to Reuters, the insulin level in the affected cartridges could be off by 50% to 150%. The danger, as the MHRA points out, is that taking too little or too much insulin can result in hypoglycemia (too little blood sugar) or hyperglycemia (too much blood sugar). Those conditions can result in a variety of problems, including blackouts. The recall was made to the patient and pharmacy level.
Novo Nordisk is not a company prone to recalls or manufacturing issues, but it is not completely immune. In its August earning release, the company said that in June, it received a Complete Response Letter (CRL) from the FDA saying that issues at a plant found during an inspection were holding up completion of the review for its recombinant factor XIII compound for a rare bleeding disorder. Novo did not delineate which plant or what issues. The company said, "Novo Nordisk is working closely with FDA to address the issues."
The CRL came on top of setbacks in other areas this year. Just this month, pharmacy benefits manager Express Scripts ($ESRX) decided not to renew its contracts in 2014 to supply its fast-growing Victoza and top-selling modern insulin NovoLog (sold as NovoRapid in the U.S.), a move that is expected to trim earnings per share by about 3% in 2014. That came after the big blow in February when the FDA turned down the application for Novo's long-acting insulin Tresiba, the first drug in a long time that analysts thought could be a solid challenger to Sanofi's ($SNY) top-selling insulin, Lantus.