The NovoLog 10mL vials (NDC 0169-7501-11 Control: NW51283) did not
circulate through the normal Novo Nordisk distribution channel and therefore
proper storage conditions for the insulin may not have been followed.
Novo Nordisk is asking any patient or customer that has NovoLog vials
marked Control: NW51283 to not use the vials and to contact the Novo
Nordisk Customer Support Department at 1-800-727-6500 as soon as possible.
NovoLog 10mL vials are readily available. Novo Nordisk continues to
have ample stock of NovoLog to supply to US customers. Novo Nordisk
stands behind the safety and quality of all of its products.
Dr. Peter Aurup, Novo Nordisk vice president of Drug Development said,
"When NovoLog 10mL vials are not stored at their proper refrigerated
temperatures, the insulin may lose its pharmacoactive potential and
not work as it is intended to for patients with diabetes. Patients may
therefore not have proper blood glucose control."
The shipment of NovoLog from the Novo Nordisk manufacturing facility
in Denmark was being held in temporary cargo storage at SAS Airlines
in Newark, NJ following US customs clearance. The product was discovered
missing when Novo Nordisk's carrier attempted to transfer it to the
company's warehouse. Because the product was not missing before July
26, 2003, consumers do not need to be concerned about NovoLog that they
obtained before then. Appropriate Federal Law Enforcement Agencies have
been contacted and an investigation into this matter is ongoing. SOURCE:
Novo Nordisk
