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2011-03-18

Recall - prescription product containing the wrong medication

Recall notice from HSW:

Note: this is directed mainly towards pharmacists, however, if you take either of the drugs, you may want to check with your pharmacist to be sure you didn't receive affected drugs - potentially life-threatening interactions could occur



Event Highlights
Health Canada reports that following a complaint by a pharmacist regarding a prescription product containing the wrong medication, Mylan Pharmaceuticals has begun a voluntary recall of one lot (1037180) of MYLAN-MINOCYCLINE 50mg capsules, (bottles of 100) and MYLAN-AMLODIPINE 5mg tablets, (bottles of 100).
According to Mylan Pharmaceuticals, the quality investigation, which is ongoing, revealed a labelling error in which the MYLAN-AMLDODIPINE 5mg tablets label was mixed with the MYLAN-MINOCYCLINE 50mg capsules labels.

See HSW Product Details tab for specifics on the affected drugs.

MYLAN-AMLODIPINE is used to treat high blood pressure and angina (chest pain). MYLAN-MINOCYCLINE is used to treat certain types of skin infections, urinary tract infections, gallbladder infections, and respiratory tract infections such as bronchitis, pneumonia, and sinusitis.

The risk to a patient, who is sensitive or allergic to tetracyclines or minocycline, and is taking MYLAN-AMLODIPINE to treat their high blood pressure or angina, but is now using MYLAN-MINOCYCLINE due to a labelling error, can be life-threatening. 

In addition, a patient who requires MYLAN-AMLODIPINE for their high blood pressure or angina will not get the medication needed to help them treat these conditions.

Recommended Actions:The company is advising pharmacists and wholesalers to return all quantities of the affected lot to Mylan Pharmaceuticals.

Canadians with high blood pressure, angina, or allergies to tetracyclines or minocycline should...
•Speak to your healthcare practitioner and pharmacist with any questions or concerns regarding further use of this product.
•Report any adverse reaction potentially related to these products to Health Canada.
•Contact Mylan Pharmaceuticals concerning this recall at 1-800-575-1379


Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

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