Novo Nordisk A/S recalled batches of its NovoMix 30 FlexPen and Penfill insulin after Europe’s drug regulator recommended patients not use the products to avoid dose variations.
The world’s biggest insulin maker told the European Medicines Agency that a manufacturing defect caused some batches to contain 50 percent to 150 percent of the labeled amount of insulin. The Bagsvaerd, Denmark-based company couldn’t say which ones had incorrect dosages, Novo spokesman Mike Rulis said.
“It’s a relatively small amount, but cost here is not an issue,” Rulis said in a telephone interview.
The recall applies to 3 million cartridges and the financial impact is minor, Rulis said. About 0.14 percent of the cartridges were affected, he said. Novo Sales of NovoMix products, also known as NovoLog, were 2.5 billion kroner ($458 million) in the second quarter.
Patients who use products from the affected batches should see their doctor or nurse to switch treatment as soon as feasible, the EMA said in a statement. The numbers of the 33 affected batches are available on the agency’s website.
Increased obesity and sedentary lifestyles around the world are kindling a surge in diabetes. The market will probably grow to more than $58 billion in 2018 from $35 billion in 2012, according to Standard & Poor’s. Diabetics fail to produce insulin or their body doesn’t use the hormone properly to convert blood sugar into energy, leaving blood-sugar levels too high without treatment.