Novo recalls injectors with potential for fatal flaw

Drugmakers are often going to sophisticated devices to help consumers give themselves injections more safely. But if something doesn’t work with the injector, it means a drug recall for the company. Novo Nordisk is now dealing with that situation.

The Denmark-based company is recalling 6 lots of its GlucaGen HypoKit, which is used for treating severe low blood sugar in patients with diabetes who take insulin. The recall came after Novo ($NOVO) received two customer complaints from the U.K. and Portugal involving detached needles on syringes that contain sterile water.

Novo said so far no adverse events have been reported, and its investigation indicated only about 0.006% of the kits might be affected, that is 1 in about 17,803. But for those patients that get a faulty injector, the risk is significant, since untreated hypoglycemia can lead to unconsciousness, seizures and death.

Last year, Mylan ($MYLN) recalled 14 lots of its 10-mL prefilled syringes of calcium chloride infusion made for Swiss drug company Amneal because there had been complaints of difficulties giving the drug because of incompatibility between the syringe and certain needleless adaptors. Calcium chloride products are considered lifesavers, injected as part of the resuscitation procedure following a cardiac arrest and for treating arrhythmias.

Another really significant injector recall came this year when Sanofi ($SNY) pulled from the market all of its Auvi-Q devices, 492,000 two-packs, because they could give the wrong dose of ephedrine, used for patients, often children, who have serious allergic reactions, or anaphylaxis.

That was a huge hit for Sanofi, but it has also played into the current troubles at Mylan, which has been severely criticized for taking large price hikes on its EpiPen. Between the Sanofi recall and the troubles of Teva Pharmaceutical getting a competing product approved, Mylan’s EpiPen dominates the market. Having been cited for raising the list price on two-packs of the pen to about $600 from about $100 over 9 years, Mylan has now assumed the mantle of price hiking poster child in the public’s eye.

- here’s the release

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