Sandoz Glimepiride recalled due to mislabelling of dosage strength on packaging

Starting date:

January 24, 2014

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product label update

Audience:

General Public

Identification number:

RA-37743

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

Issue

Sandoz Canada Inc., in consultation with Health Canada, is voluntarily recalling one lot of its health product, glimepiride, that is used to treat diabetes, due to the mislabelling of boxes. While the outer carton of the product is labelled as containing 1 mg tablets, the blister package inside may contain 2 mg tablets.

This potentially poses a serious risk to consumers as a greater than prescribed dose of glimepiride can cause hypoglycemia (low blood sugar). Elderly patients are at increased risk of hypoglycemia, and their symptoms may be harder to notice. Symptoms include weakness, drowsiness, blurred vision, headache, sweating and confusion. In extreme cases, hypoglycemia may cause loss of consciousness, seizures, or death.

No adverse reactions related to this problem have been reported to Health Canada or Sandoz Canada Inc.

Products affected

Sandoz glimepiride 1 mg and 2 mg

DIN 02269589 and 02269597, Lot (L) DM5336, Expiry date: 2014-12

What you should do

• If you are prescribed this drug, you should check the lot number of the outer package or the blister pack. The recalled product lot number is (L) DM5336.
• Consumers who have this lot in their possession should return the product to the place of purchase and receive replacement product.
• Consult your health care practitioner immediately if you believe you have used an incorrect dosage strength of this product.
• Report any adverse events using this product to Health Canada.

For more information:

More information is available from Sandoz Canada Inc. by calling 1 (800) 343-8839 or on their website at www.sandoz.ca.

Sandoz Canada Inc.

145 Jules Léger

Boucherville, Quebec   J4B 7K8

Who is affected

Canadians who use this product, especially the elderly.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall of the affected lot of Sandoz glimepiride.