APO-QUETIAPINE XR - May exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP).
Last updated
Summary
Product
APO-QUETIAPINE XR
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Distribution
National
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot numbers |
|---|---|---|---|---|---|
APOTEX |
APO-QUETIAPINE XR 50mg |
DIN 02457229 |
Tablet (Extended Release) |
Quetiapine fumarate 50mg |
M2213002, M2213003 & M2214445 |
APOTEX |
APO-QUETIAPINE XR 200mg |
DIN 02457245 |
Tablet (Extended Release) |
Quetiapine fumarate 200mg |
M2214011 & M2214015 |
Issue
Affected lots may exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP).
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Wholesalers & Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Apotex Inc. 150 Signet Drive, Toronto, ON M9L 1T9
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type I
Identification number
RA-76888
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