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Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose - Unaffected Product Has Now Become Available - For Health Professionals

Starting date:
October 14, 2014
Posting date:
October 14, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-41809

This is duplicated text of a letter from Mylan Pharmaceuticals ULC. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information Update on Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose

October 14, 2014

Dear Health Care Professional,

Subject: Update for Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose (DIN: 02243588) - Unaffected Product Has Now Become Available

Mylan Pharmaceuticals ULC, in consultation with Health Canada, is providing additional information as a follow-up to the communication sent on September, 22, 2014, regarding the potential of defective pumps in certain lots of Mylan-Nitro Sublingual Spray 0.4 mg/metered dose (DIN: 02243588). Unaffected product has now become available in limited supply and will be shipped to pharmacies and wholesalers.

  • Patients who have received the affected product (see table below) should continue to use it following the instructions previously provided, which directs them to use each canister currently in their possession for about 70-75 sprays (a third of its content).
  • When each previously dispensed canister from the affected lots has been used for 70-75 sprays, it will require replacement. At the time of prescription refill, patients will be provided with one unaffected product canister available in stock.
  • Pharmacists should clearly explain to patients that the product they are now receiving is unaffected, as indicated by the two verification labels affixed (see picture below), and the new canister should be fully used up to the regular rate of 200 prescribed doses.
  • For a period of time patients may have in their possession both affected and unaffected canisters. Pharmacists will need to clearly explain the use of each.
  • Patients should be reminded to always have a spare spray canister readily available for use in case their current canister runs out of medication or fails to work properly.

This recall is extended to the pharmacy and wholesaler level and applies only to product not yet dispensed. Pharmacists and healthcare professionals are not required to contact patients and advise them to return the product they have received.

The lot numbers of affected product being recalled are:
Lot Number Expiry Date
2L734 Nov-14
2L731 Nov-14
3E830 May-15
3E828 May-15
3F834 June-15
3F837 June-15
3K873 Oct-16
3K877B Oct-16
4B948 Feb-17
4B949 Feb-17
4D973 Apr-17

Distribution of affected product lots should be stopped and existing stock returned to Mylan only once unaffected product is received. In order to clearly identify unaffected product, each unit of unaffected product will have two verification labels: one affixed to the top of the canister closure, and one on a side of the canister carton, respectively, as depicted in the picture below.

Mylan-Nitro Sublingual Spray 0.4 mg per Metered Dose

Product released by Mylan for distribution within the next twelve months will continue to be marked with verification labels, in order to address any potential confusion between previously distributed affected product, which may be with patients, and new unaffected product lots.

Mylan Pharmaceuticals ULC has continued to diligently work on resolving this issue as quickly as possible and resuming regular product supply.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious adverse reactions, or unexpected adverse reactions in patients receiving Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose should be reported to Mylan Pharmaceuticals ULC or Health Canada.

Mylan Pharmaceuticals ULC
85 Advance Road, Etobicoke, ON
M8Z 2S6
Mylan ULC Customer Relations
Phone: 1-800-575-1379
Fax: 1-855-236-2990
E-mail: customerservice@mylan.ca

To correct your mailing address or fax number, contact Mylan Pharmaceuticals ULC.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

Sincerely,

original signed by

Anca Schmidt
Senior Director, Quality
Mylan Pharmaceuticals ULC


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For more information

The manufacturer advised Health Canada of the risk associated with this health product's quality. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.