Octreotide for injectable suspension; Good manufacturing practices concerns
Brand(s)
Last updated
Summary
Product
Octreotide for injectable suspension
Issue
Health products - Product quality
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. Seek medical attention if you have used this product and are experiencing symptoms of infection, or other unexpected symptoms or side effects.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot Number |
|---|---|---|---|---|---|
| Teva Canada Ltd. | Octreotide for injectable suspension 10 mg/vial | DIN 02503751 | Kit, Powder For Suspension, Sustained-Release | Octreotide acetate 10 mg/vial | 4401203R, 4401202, 4400915 |
| Teva Canada Ltd. | Octreotide for injectable suspension 20 mg/vial | DIN 02503778 | Kit, Powder For Suspension, Sustained-Release | Octreotide acetate 20 mg/vial | 4501460, 4401309, 4401501, 4401231, 4401065 |
| Teva Canada Ltd. | Octreotide for injectable suspension 30 mg/vial | DIN 02503786 | Kit, Powder For Suspension, Sustained-Release | Octreotide acetate 30 mg/vial | 4501296, 4401394, 4500804, 4500219, 4401208, 4500218, 4401207, 4400955, 4400918 |
Issue
Quality concerns of affected lots due to deficiencies in Good Manufacturing Practices (GMP).
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.
Related recalls and alerts
Additional information
Background
Depth of recall: End users
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Teva Canada Limited
30 Novopharm Court, Unit A,
Toronto, ON, M1B 2K9, Canada
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-81480
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
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