Bausch Health in Canada is recalling all current lots of Emerade epinephrine auto-injectors due to the risk of mechanical failure.
Health Canada, the government health agency, announced on May 5 the company’s recall of Emerade auto-injectors in 0.3 mg and 0.5 mg strengths. The agency noted that “testing by the company identified the potential risk that the auto-injector may fail to activate, or it may activate prematurely if dropped.”
Then on May 9, the U.K.’s Medical and Healthcare Products Regulatory Agency (MHRA) also recalled the Emerade epinephrine injectors for the British population. The MHRA cited the same possible device risks. In the U.K., the Emerade pens are sold as 300 or 500 microgram strengths.
Health Canada stressed the importance of the recall to patients who are at risk for serious reactions. “Failure of the auto-injector to activate may result in patients not receiving the required dose of epinephrine, leading to the worsening of symptoms of anaphylaxis which could be life-threatening,” it said in a statement.
What to Do if You Own an Emerade?
In Canada, Health Canada says to:
• Contact the pharmacy where you bought your Emerade devices. Request a set of replacement epinephrine auto-injectors, as soon as possible. Ensure you understand how a different device works. (In Canada, Allerject, known as Auvi-Q in the U.S., and EpiPen epinephrine injectors are widely available.)
• Keep your Emerade auto-injectors until you can get the alternative brand devices.
• In case of anaphylaxis before you can pick up your new injectors, “use the Emerade device.” The agency says to then seek emergency medical attention.
• Contact Bausch Health, Canada if you have recall questions. Phone 1-800-361-4261 or email [email protected].
In Britain, the MHRA gave similar replacement advice to patients who own Emerade auto-injectors. However, as a prescription is required, those patients will need to contact their doctors for a new prescription before contacting their pharmacy. Read more here.
Health Canada does not anticipate any shortage of other epinephrine devices. It says: “the Department will continue to actively monitor the supply situation.” The MHRA’s chief safety officer says the U.K. government “has confirmed that there are appropriate supplies of EpiPen or Jext adrenaline pens available for patients across the U.K.”
Bausch Health introduced the Emerade auto-injector in Canada in 2020. It is known in Canada and in Europe for the higher dose 0.5 mg epinephrine strength.
See Health Canada’s May 2023 recall announcement here. MHRA’s U.K. statement is here.