Teva Octreotide for injectable suspension recalled due to potential drug quality issues
Summary
If you have an affected product, do not use it. Speak to your health care professional immediately to obtain an alternative or replacement product. Seek medical attention if you have used this product and are experiencing symptoms of infection, or other unexpected symptoms or side effects.
Affected products
| Product | DIN | UPC | Lot | Expiration date |
|---|---|---|---|---|
| Teva Octreotide for injection 10 mg/vial - kit | 02503751 | 068510998460 |
|
|
| Teva Octreotide for injection 20 mg/vial - kit | 02503778 | 068510998477 |
|
|
| Teva Octreotide for injection 30 mg/vial - kit | 02503786 | 068510998484 |
|
|
Issue
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 you should 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.
Additional information
Details
Media and public enquiries
Media Enquiries:
Health Canada
613-957-2983
media@hc-sc.gc.ca
Public Enquiries:
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca
Get notified
Receive emails about new and updated recall and safety alerts.