Mylan Pharmaceuticals recalling nitroglycerin spray due to defective pump

Starting date:
September 20, 2014
Posting date:
September 20, 2014
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information, Product withdrawal
Audience:
General Public
Identification number:
RA-41497

Issue

Mylan Pharmaceuticals ULC Canada, in consultation with Health Canada, is voluntarily recalling all lots of its Mylan-Nitro Spray 0.4 mg/metered dose due to the product missing the "dip tube," which is part of the pump component.

A missing "dip tube" could pose a potential problem with the delivery of nitroglycerin to the patient. This defect may lead patients to believe they are receiving the nitroglycerin, when in fact they are unable to access it. Not receiving nitroglycerin could place them at risk for either a delay in treatment for their angina or of suffering a heart attack.

Products affected

  1. Mylan-Nitro Spray 0.4 mg/metered dose (Lots: 2L734, 2L731, 3E830, 3E828, 3F834, 3F837, 3K873, 3K877B, 4B948, and 4B949)

What you should do

  • Return the product to the pharmacist and get a replacement.
  • Speak to your healthcare provider if you have any concerns regarding the use of this product.
  • Report any adverse events to Health Canada.

Who is affected

Canadians who are using the Mylan-Nitro Spray (0.4 mg/metered). The company has indicated that it has not received reports of any adverse events associated with the defective product.

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.

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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 and working with the company to help ensure patients and healthcare professionals are informed. Health Canada will provide an update to Canadians, as necessary.

For more information

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.