Two lots of Omnitrope injectable human growth hormone recalled due to cracked cartridges

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.