- Danish drugmaker Novo Nordisk last week recalled six batches of GlucaGen HypoKit, an injectable treatment for hypoglycemia, after two customer complaints concerning detached needles on the product syringe.
- The complaints were received in the U.K. and Portugal, but Novo has initiated the recall in the U.S. as well. Roughly 71,215 pens are covered in the product callback.
- In an investigation into the matter, Novo found 0.006% of needles could detach from the syringe.
Novo launched GlucaGen HypoKit in 2005. The product includes a vial with freeze-dried glucagon along with a prefilled syringe containing sterile water used to reconstitute the glucagon.
The HypoKit is intended as an emergency kit for treatment of severe hypoglycemic reactions in people with insulin-dependent diabetes.
Without the needle, the kit cannot be used correctly.
Novo recalled six batches, which were distributed to wholesalers, pharmacies, and patients in the U.S. beginning on February 15. Novo plans to reimburse patient out-of-pocket costs incurred through purchase of an affected kit.