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Sandoz Glimepiride Recalled Due to Mislabelling of Dosage Strength on Packaging

OTTAWA, ONTARIO -- (Marketwired) -- 01/25/14 --

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.

Who is affected:

Canadians who use this product, especially the elderly.

What consumers 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. 

What Health Canada is doing:

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

Products recalled/affected:                                                 
Sandoz glimepiride 1 mg and 2 mg                                            
DIN 02269589 and 02269597, Lot (L) DM5336, Expiry date: 2014-12             

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 Leger            
Boucherville, Quebec J4B   
7K8                        

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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Egalement disponible en francais

Contacts:
Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866-225-0709

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