Canada Recalls Two Omnitrope Lots Over Cracked and Leaking Cartridges
- By Tahani Elghazaly
- Published
Canadian health authorities have recalled two lots of Omnitrope, a prescription human growth hormone medication, after reports of cracked and leaking glass cartridges that could compromise the product's safety and effectiveness.
According to Health Canada, the recall affects Omnitrope 5 mg/1.5 mL (somatropin) manufactured by Sandoz Canada. Officials warned that damaged cartridges may allow contamination or cause medication to leak, potentially resulting in patients receiving a lower dose than prescribed.
The recalled products include:
- Omnitrope 5 mg/1.5 mL – One-cartridge package, Lot PR7350, DIN 02325063, expiry date April 30, 2027.
- Omnitrope 5 mg/1.5 mL – Five-cartridge package, Lot PR7351, DIN 02325063, expiry date April 30, 2027.
Health Canada said using medication from a cracked cartridge may increase the risk of contamination, potentially leading to infections at the injection site or, in rare cases, infections elsewhere in the body. Small glass particles from damaged cartridges could also cause tissue irritation or localized abscesses.
The agency noted that medication leakage may reduce the amount of growth hormone delivered, which could decrease the effectiveness of treatment if patients receive lower-than-prescribed doses over an extended period.
Omnitrope contains somatropin, a synthetic form of human growth hormone administered by subcutaneous injection. It is prescribed for children and adults with growth hormone deficiency and for certain pediatric growth disorders, including Turner syndrome.
Patients and caregivers are advised to check the lot number on their medication before use. Anyone with an affected product should stop using it immediately and return it to their pharmacy for replacement and safe disposal.
Health Canada also recommends consulting a physician or pharmacist before interrupting or changing treatment. Patients experiencing redness, swelling, pain, or any unusual symptoms after using the recalled medication should seek medical attention.
The department said it is overseeing the recall and monitoring the manufacturer's investigation, adding that further updates will be issued if additional health risks are identified.
You May Also Like
Authors
-
Tahani Elghazaly5352 Posts
Popular Posts
Newsletter
Subscribe to our mailing list to get the new updates!