Health Canada has issued a public advisory recalling two lots of Omnitrope (5 mg/1.5 mL somatropin) injectable human growth hormone due to reports of cracked and leaking glass cartridges. The recall affects products distributed nationally by Sandoz Canada Inc.
Affected Products and Lot Numbers
The recall applies to Omnitrope 5 mg/1.5 mL somatropin in box of 1 cartridge (DIN 02325063, lot PR7350, UPC 0575132157422, expiry 2027-04-30) and box of 5 cartridges (DIN 02325063, lot PR7351, UPC 0575132157592, expiry 2027-04-30). Consumers are advised to check their medication and return affected products to their pharmacy for replacement and proper disposal.
Risks Associated with Cracked Cartridges
Cracked and leaking cartridges may lead to contamination and infection, as well as lower doses than intended. Injecting contaminated Omnitrope subcutaneously could cause local or systemic infection, while glass particles may irritate tissue or lead to abscesses. Reduced dosage over weeks may diminish the drug's effectiveness.
Omnitrope is a prescription drug containing somatropin, a human growth hormone administered by subcutaneous injection. It is used to treat adults and children with growth hormone deficiency, children who have not reached normal growth by age two, and those with Turner syndrome.
Health Canada's Response
Health Canada is monitoring Sandoz Canada's recall and investigation, including corrective and preventive actions to prevent recurrence. The agency will inform the public if new risks emerge.
Consumer Guidance
Do not use recalled product. Contact your pharmacy for a replacement and return the product for proper disposal. If you or your child experience unusual symptoms such as persistent redness, swelling, pain at the injection site, or fever, consult a healthcare professional. For questions, call Sandoz Canada toll-free at 1-800-343-8839. Report side effects or complaints to Health Canada.
This recall is classified as Type I (high risk) and is distributed nationally.
