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).
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.
While this continues to remain a recall situation, in view of updated information that indicated a drug shortage would result from an immediate recall, Mylan Pharmaceutical is requesting that pharmacists provide affected consumers with two new spray canisters of Mylan-Nitro Spray 0.4 mg/metered dose. This temporary solution is aimed at ensuring that all patients have enough medicine for the immediate future.
The potential frequency of canisters missing "dip tubes" is very low, but canisters can still reliably deliver between 70 and 75 doses rather than the usual 200 sprays, according to the company.
In order to help Canadians maintain their health, Health Canada considered all factors, including the risk of a possible short-term disruption in their treatment, the medical necessity of the product involved, the availability of alternative products, and risk assessments.
Mylan Pharmaceuticals ULC has informed Health Canada that it continues to work on resolving the issue as quickly as possible and resuming a non-defective product supply. Once the supply has been stabilized and unaffected product becomes available, remaining product from the affected lots will be removed from the market.
The company is advising consumers to: See your pharmacist for two (2) replacement canisters. Patients are also advised to renew their supply about three times more often than usual, or as they approach 70 sprays with a single canister, whichever comes first; Patients should always have a spare canister spray readily available for use in case their current canister runs out of medication or fails to work properly; Patients should not exceed the maximum recommended dose and should seek medical attention immediately if symptoms persist; Patients using Mylan-Nitro Spray 0.4 mg/metered dose should contact their healthcare professional regarding available alternative therapies if they have concerns with using the product; Not receiving nitroglycerin places patients at risk of a delay in treatment for their angina or of suffering a heart attack.
The company is advising that patients should not attempt to open their current canister of Mylan-Nitro Spray 0.4 mg/metered dose to determine if the "dip tube" is missing, or to access the nitroglycerin spray directly.
Health Canada is monitoring this situation closely and working with the company to help ensure patients and healthcare professionals are informed. Health Canada will provide further update to Canadians as necessary.