MONTREAL, June 13, 2015 /CNW Telbec/ - Sanofi-aventis Canada Inc. (Sanofi Canada) is taking the precautionary measure of issuing a Voluntary Recall of Allerject 0.15 mg / 0.15 mL epinephrine auto injectors, lots 2857505 and 2857508, distributed as of June 1st, 2015, due to a manufacturing defect potentially affecting the delivery of the drug. This defect was discovered as part of a routine manufacturer quality review process. Allerject 0.15 mg / 0.15 mL is the pediatric version of the epinephrine auto injector. No other lots or strengths of Allerject, or any other Sanofi Canada products are included in this recall. The lots subject to the recall were distributed solely in Canada. There have been no reports of patients adversely affected by the 2 lots distributed to date.
Should an individual be in possession of the products in lots 2857505 and 2857508, distributed as of June 1, they should return the product to their local pharmacy for replacement. Any questions or concerns regarding this voluntary product recall, please contact the Allerject Call Center at 1-855-405-4321.
Sanofi is committed to the health and well-being of patients/consumers using its products. This voluntary recall is conducted in collaboration with the Health Products and Food Branch Inspectorate of Health Canada which has issued a communications relating to the recall. LINK
Sanofi Canada is contacting health care professionals and stakeholders involved in the treatment of anaphylaxis.
French: Allerject 0.15 mg / 0.15 mL epinephrine injection, Lot: 2857505, Expiry date: Sept 2016, UPC: 065914 11217 1
English: Allerject 0.15 mg / 0.15 mL epinephrine injection Lot: 2857508, Expiry date: Sept 2016, UPC: 065914 11216 4
Note that other lots are NOT affected by this recall
About Sanofi – www.sanofi.ca
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi entities in Canada include Sanofi Canada (pharmaceuticals), Sanofi Pasteur (vaccines), Sanofi Consumer Health (cosmeceuticals, over-the-counter products and specialty care), Genzyme (rare diseases) and Merial (animal health). Together they employ close to 1,700 people. In 2014 Sanofi companies invested $130.5 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
SOURCE Sanofi Canada
Image with caption: "Allerject 0.15 mg / 0.15 mL epinephrine auto injector (CNW Group/Sanofi Canada)". Image available at: http://photos.newswire.ca/images/download/20150613_C7206_PHOTO_EN_18101.jpg