Immediate Recall by Mylan Pharmaceuticals: Potential Serious Risk due to Mislabelling of Products

Starting date:

March 17, 2011

Posting date:

March 17, 2011

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Labelling and Packaging

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110004898

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

Issue

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 50 mg capsules, (bottles of 100) and Mylan-Amlodipine 5 mg tablets, (bottles of 100).

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.

The company is advising pharmacists and wholesalers to return all quantities of the lot (1037180) to Mylan Pharmaceuticals.

Products affected

1. Mylan-Minocycline 50 mg capsules
2. Mylan-Amlodipine 5 mg tablets

What you should do

• 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 (see below).
• Contact Mylan Pharmaceuticals concerning this recall at 1-800-575-1379

Who is affected

Canadians with high blood pressure, angina, or allergies to tetracyclines or minocycline.

Background

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.

According to Mylan Pharmaceuticals, in mid-March, Mylan Pharmaceuticals received a complaint sample from a pharmacist. The pharmacist reported that she had ordered four 100-count bottles of Mylan-Minocycline 50 mg capsules, and had received instead three Minocycline bottles correctly containing 100 Mylan-Minocycline 50 mg capsules. However, the fourth bottle received as part of this order was labelled as Mylan-AmlodipineE 5 mg Tablets, but contained 100 Mylan-Minocycline 50 mg capsules. Upon examination of the complaint sample, Mylan Pharmaceuticals noticed that the lot number (1037180) and expiry date (May 2013) printed on the Mylan-Amlodipine complaint bottle label corresponds to a lot of Mylan-Minocycline 50 mg capsules, bottles of 100.

According to Mylan Pharmaceuticals, the quality investigation, which is ongoing, revealed a labelling error in which the Mylan-Amlodipine 5 mg tablets label were mixed with the Mylan-Minocycline 50 mg capsules labels.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Facsimile: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  
  Marketed Health Products Directorate
  
  Ottawa, ON, Address Locator 0701E
  
  K1A 0K9

Media enquiries

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

Public enquiries

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.

What Health Canada is doing

Health Canada is monitoring the company's recall and should any new information be identified, we will continue to provide updates to Canadians.