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Health Canada Health products

Sandoz Glimepiride recalled due to mislabelling of dosage strength on packaging

Issued January 24, 2014
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.
What to 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