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Information update

Updated consumer information on Mylan Pharmaceuticals nitroglycerin spray recall

Starting date:
October 15, 2014
Posting date:
October 15, 2014
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety
Audience:
General Public
Identification number:
RA-41821

Issue

Health Canada is advising Canadians that Mylan Pharmaceuticals ULC has begun a voluntary recall of certain lots of its Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose to the retail level. The recall is a result of the product potentially missing the "dip tube," which is part of the pump component. A missing "dip tube" could pose a problem with the delivery of nitroglycerin to the patient.

Health Canada had previously informed Canadians about this issue, but the recall was initially delayed due to the possibility of creating a shortage of this medically necessary heart drug on the Canadian market.

Health Canada would also like to inform Canadians that Mylan Pharmaceuticals ULC is now releasing product from a different lot that had been set aside and now verified to have a "dip tube" by the company. Consumers should verify that there is a checkmark sticker on the product's canister closure and carton, which demonstrates that it has the "dip tube".

In order to help ensure ongoing supply of the product, the company is advising consumers to continue using their current canister and only refill their prescription once one-third of their spray (70-75 doses) has been used.

Consumers should consult their pharmacist or healthcare practitioner if they have any concerns regarding the use of this product and report any adverse events to Health Canada.


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866 225-0709

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