Levemir insulin - Lot numbers XZF0036, XZF0037, and XZF0038

Foreign Product Alert
2009-95
June 18, 2009
For immediate release

Health Canada is advising consumers not to use the following products specified below due to concerns about possible side-effects. More info

Source of Alert: U.S. Food and Drug Administration (FDA)
Product Names: Levemir insulin - Lot numbers XZF0036, XZF0037, and XZF0038
Manufacturer / Place of Origin: Novo Nordisk Inc., Princeton, New Jersey, USA

Product Description
Levemir insulin is used to treat type 1 diabetes in adults and children, and type 2 diabetes in adults who require long-acting insulin to control high blood sugar. The product, which is administered by injection, is packaged in 10 ml vials.

Photo: 10 ml vial of Levemir (insulin detemir [rDNA origin] injection)

Reason for Warning
The FDA warned consumers not to buy or use three lots of Levemir insulin vials (lot numbers XZF0036, XZF0037, and XZF0038). These lots, which were reported stolen in the U.S., have reappeared for sale on the U.S. market. The three lots, totalling 129,000 vials, may not have been stored and handled properly and may pose a serious risk to health.

The FDA is advising U.S. consumers to:

1. Check your personal supply of insulin to determine if you have Levemir insulin vial from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.
2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.
3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

Possible Side-Effects
The FDA has received one report of a patient who suffered an adverse event due to poor control of blood sugar levels after using a vial from one of these three lots.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.