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Displaying 1 - 15 of 238 items.
A new presentation of SPIKEVAX (elasomeran) with a concentration of 0.10 mg/mL in a 2.5 mL multidose vial was authorized on June 01, 2022. In order to provide rapid access to the new presentation of SPIKEVAX (0.10 mg/mL, 2.5 mL multidose vial), Moderna…
AlertHealth professional risk communication | 2022-06-06
Surestrips Covid-19 Antigen Tests are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. Artron Laboratories Inc.).
Recall start date…
RecallHealth product recall | 2022-05-30
Sotrovimab, 500 mg IV, is unlikely to maintain efficacy against the Omicron BA.2 subvariant. Sotrovimab demonstrates reduced in vitro neutralization against the Omicron BA.2 subvariant.
Audience
Healthcare professionals responsible…
AlertHealth professional risk communication | 2022-04-14
EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…
AlertHealth professional risk communication | 2022-04-14
NUVAXOVID was authorized by Health Canada on February 17, 2022. In order to provide earlier access to NUVAXOVID in the context of the global pandemic, Novavax, Inc. will distribute product vials, cartons and package inserts that are in English only for a…
AlertHealth professional risk communication | 2022-02-23
Affected lot(s) may be missing risk statements and the non medicinal ingredient carbomer on the outer label.
RecallHealth product recall | 2022-02-23
The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.
RecallHealth product recall | 2022-02-08
The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.
RecallHealth product recall | 2022-02-08
UPDATED INFORMATION - July 6, 2022
A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to…
AlertHealth professional risk communication | 2022-01-17
There is a high risk of treatment failure with the casirivimab and imdevimab combination based on analysis of neutralization activity against selected mutations of the SARS-CoV-2 Omicron variant. The Canadian Product Monograph for casirivimab and…
AlertHealth professional risk communication | 2022-01-07
The manufacturer confirmed that some SARS-COV-2 Rapid Antigen Test Nasal kits lots were erroneously distributed with Medico swabs, which are not included in the current Health Canada interim order authorization for that kit.…
RecallHealth product recall | 2021-11-26
The importer was informed that the specifications do not meet the requirements or the laboratories were not reliable/verifiable. Not all respirators meet the minimum 95% filtration rate required.
Recall start date: 2021-05-28…
RecallHealth product recall | 2021-11-26
These respirators do not meet the prescribed standard of KN95. There is insufficient evidence to support their safety and effectiveness. This recall affects Hynaut KN95 protective face mask models C004, C012, A048, A058, and A059…
RecallHealth product recall | 2021-11-19
When we imported these items 18 months ago, we provided the test results for the KN95 but later learned these results were from the correct manufacturer but for a different model or size. We have no reason to suspect they are bad but now…
RecallHealth product recall | 2021-11-19
LUCIRA CHECKIT COVID-19 TEST KIT (2021-10-08)
Starting date:
October 8, 2021
Posting date:
October 22, 2021
Type of communication:
Medical Device Recall
Hazard classification…
RecallHealth product recall | 2021-10-22