Insulin detemir alert issued by FDA
Stolen, mishandled Levemir product
reported.
FDA announced today that some stolen vials of the basal insulin
product Levemir (Novo Nordisk) have reappeared and are being sold on the
U.S. market. Pharmacists should remove vials with the following lot
numbers of this insulin detemir product from inventory: XZF0036,
XZF0037, and XZF0038. One report of a patient who suffered an adverse
event due to poor control of glucose levels after using a vial from one
of these three lots has been reported to FDA.
In all, three lots totaling 129,000 vials of Levemir were stolen. FDA
said that, because these stolen insulin vials may not have been stored
and handled properly, they may be dangerous for patients to use.
FDA is advising health professionals and patients who use Levemir
insulin to check for the above lot numbers and if found, replace them
with vials from a different lot. Patients in possession of vials with
these lot numbers should obtain replacement product and unable to obtain
alternative lots of Levemir, contact their health professional about
other insulin products and needed dosage adjustments.
Patients and professionals should contact the Novo Nordisk Customer
Care Center at 800-727-6500 for procedures concerning these lots or with
other questions.
Web links
L. Michael Posey, BPharm (mposey)
Posted June 13, 2009, 4:00 pm EDT
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