Two lots of Allerject epinephrine-auto-injectors have been recalled in Canada due to “a manufacturing defect that may prevent the device from working properly.”
The recall involves about 3,000 Allerject devices that were distributed as of June 1, 2015 – with the lot numbers 2857508 and 2857505. These specific auto-injectors contain a 0.15 mL (0.15 mg) epinephrine dose intended for children weighing 15 to 30 kgs.
According to Health Canada, a defect was detected with the needle and as a result, the identified lots might not deliver epinephrine properly during anaphylaxis, which could pose serious health risks to patients.
The problem was discovered during a routine review of the manufacturing process, according to Sanofi Canada, the distributor of the auto-injector. The pharmaceutical company opted to voluntarily recall the auto-injectors as a precaution.
No adverse events related to the recalled lots have been reported. This recall only applies to auto-injectors distributed in Canada. It does not apply to similar devices sold in the United States.
What to Do:
‚Ä¢ Canadian parents with allergic children are advised to check a child’s Allerject. If the lot number is one of those recalled, take the device to a pharmacy to switch it for a replacement.
‚Ä¢ The replacement device will be the same dose, but may be a different form of auto-injector, so health officials recommend speaking with the pharmacist to learn how to properly administer the medication if necessary.
‚Ä¢ If anyone thinks their child has had an adverse event, please report it to Health Canada here.
‚Ä¢ Pharmacists may get in touch with the Sanofi customer service 1-800-265-7927 for further assistance.
“Sanofi’s number one priority is patient safety and product supply,” said Sanofi spokesperson Joanne Kennedy. “As pharmacy supply varies based on their inventories, to ensure safety of the patient, Sanofi will work with retail pharmacists to facilitate replacement or refund of devices identified in this voluntary recall.”
Health Canada confirmed that aside from the two specific lots included in the recall, all other epinephrine auto-injectors in the marketplace, including other Allerjects, are considered safe and effective.
“No other lots or strengths of Allerject, or any other Sanofi Canada products are included in this recall,” said Kennedy. “We continue to have confidence in the safety and efficacy of Allerject.”
If you have any further questions or concerns, Health Canada is encouraging Canadians to speak to their health-care provider.
For the official Health Canada recall notice, click here.