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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
- Products affected
- What you should do
- Who is affected
- Report health or safety concerns
- Related AWRs
- Media enquiries
- Public enquiries
- What Health Canada is doing
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
- 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.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Related AWRs
Additional information on Mylan Pharmaceuticals nitroglycerin spray recall
2014-09-21 | Health products
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.