Canada
Omnitrope 5 mg/1.5 mL somatropin cartridges (Box of 1, DIN 02325063, Lot PR7350, UPC 057513215742; Box of 5, DIN 02325063, Lot PR7351, UPC 057513215759; expiry 2027-04-30) are recalled after complaints of cracked and leaking glass cartridges. Cracked or leaking cartridges may cause contamination and infection, glass particles and local tissue irritation, or deliver lower than intended doses. If you have a recalled product, do not use it; contact your pharmacy immediately for a replacement and return the product to your pharmacy for proper disposal, and consult a healthcare professional if you experience any unusual symptoms.
How to identify it
Product: Omnitrope (5 mg/1.5 mL somatropin) - Box of 1 cartridge; DIN: 02325063; Lot: PR7350; UPC: 057513215742; Expiry: 2027-04-30
Product: Omnitrope (5 mg/1.5 mL somatropin) - Box of 5 cartridges; DIN: 02325063; Lot: PR7351; UPC: 057513215759; Expiry: 2027-04-30
The hazard
Sandoz Canada Inc. is recalling two lots of Omnitrope 5 mg/1.5 mL somatropin after receiving complaints of cracked and leaking glass cartridges. Cracked and leaking cartridges may lead to contamination and infection, and to lower doses than intended.
Omnitrope is a prescription drug that contains somatropin, a human growth hormone that is administered by subcutaneous injection (under the skin). Omnitrope is used to treat both adults and children with growth hormone deficiency, and to treat children who have not reached or maintained normal growth by the age of two years, or who have Turner syndrome.
Injecting contaminated Omnitrope subcutaneously may lead to local or systemic infection (i.e., near the injection site or throughout the body). Glass particles may cause local tissue irritation and may lead to local tissue infections or abscesses (pus-filled lumps). Lower doses of Omnitrope over a long period of time (weeks) may also reduce its effectiveness.
Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions to prevent this issue from reoccurring, and will inform the public if new risks are identified.
What to do
If you have a recalled product, do not use it. Contact your pharmacy immediately for a replacement. Return the recalled product to your pharmacy for proper disposal.
If you or your child have used this product and experience any unusual symptoms (e.g. persistent redness, swelling and/or pain at the injection site, fever) or have any other health concerns, consult a healthcare professional.
Contact Sandoz Canada Inc. by calling toll-free at 1-800-343-8839 if you have questions about this recall.
Report any health product-related side effects or complaints to Health Canada.
Where it was sold
National
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)