Canada
All strengths of Teva Octreotide for Injectable Suspension Kit (DINs 02503751, 02503778 and 02503786; affected lot numbers listed in the notice) are affected. They were recalled because Good Manufacturing Practices deficiencies at the foreign manufacturing site could cause microbiological contamination, foreign particles, or dosing accuracy problems. If you have an affected product, do not use it—speak to your health care professional for an alternative or replacement, return it to the pharmacy, and seek medical attention for any symptoms.
How to identify it
Product: Teva Octreotide for injection 10 mg/vial - kit; DIN: 02503751; UPC: 068510998460; Lot: 4401203R 4401202 4400915; Expiration date: 31 Oct 2026 30 Sep 2026 31 Aug 2026
Product: Teva Octreotide for injection 20 mg/vial - kit; DIN: 02503778; UPC: 068510998477; Lot: 4501460 4401309 4401501 4401231 4401065; Expiration date: 31 Mar 2027 30 Sep 2026 31 Oct 2026 30 Sep 2026 30 Sep 2026
Product: Teva Octreotide for injection 30 mg/vial - kit; DIN: 02503786; UPC: 068510998484; Lot: 4501296 4401394 4500804 4500219 4401208 4500218 4401207 4400955 4400918; Expiration date: 28 Feb 2027 31 Oct 2026 31 Oct 2026 30 Sep 2026 30 Sep 2026 30 Sep 2026 30 Sep 2026 30 Sep 2026 31 Aug 2026
The hazard
Teva Canada Limited is recalling all strengths (lots listed above) of the prescription drug Octreotide as a precautionary measure due to deficiencies in Good Manufacturing Practices (GMP) identified at its foreign manufacturing site. GMPs ensure drugs meet the appropriate quality standards for their intended use before they are sold. The deficiencies identified could lead to potential quality issues with the products, including microbiological contamination (leading to compromised sterility), contamination with foreign particles and concerns related to dosing accuracy.
Potential serious health risks associated with these deficiencies include:
Skin and muscle infections at the injection site, including cellulitis or abscess
Severe blood infection
Blood clots
Hypersensitivity reactions, including life threatening allergic reactions
Inflammatory reactions/lumps at the injection site
Lack of therapeutic effect due to an insufficient dose
Symptoms of overdose, such as hot flushes, frequent urination, fatigue, depression, anxiety and lack of concentration, or worsened side effects.
Teva Octreotide acetate for injectable suspension is a long-acting prescription medication used to treat certain hormone-related disorders, including acromegaly (a condition caused by too much growth hormone), as well as severe diarrhea and flushing caused by certain tumors.
Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions. The Department will inform the public if any new health risks are identified.
What to do
If you have an affected product, do not use it. Speak to your health care professional immediately to obtain an alternative or replacement product. If you are unsure whether your product is affected, check with your pharmacy.
Seek medical attention if you have used this product and are experiencing symptoms of infection, or other unexpected symptoms or side effects.
Return affected product(s) to the pharmacy where it was purchased for proper disposal.
Consult a health care professional if you have used the affected product and have health concerns.
Contact Teva Canada Limited by calling toll-free at 1-800-268-4127, option 3, or by email at druginfo@tevacanada.com, if you have questions about this recall.
Report any health product-related side effects or complaints to Health Canada.
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)