Other safety alerts
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| Canada: Update for Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose (DIN: 02243588) – Unaffected Product Has Now Become Available |
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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. Unaffected product has now become available in limited supply and will be shipped to pharmacies and wholesalers.
Pharmacists should clearly explain to patients that the product they are now receiving is unaffected, as indicated by the two verification labels affixed, 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.
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.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../41809a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news were previously released by Health Canada and were posted on the Drug Office website on 22 and 23 September 2014.
Ends/ Wednesday, October 15, 2014
Issued at HKT 12:30
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