QUETIAPINE XR : Affected lots may exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP)
Brand(s)
Last updated
Summary
Product
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 |
|---|---|---|---|---|---|
| SIVEM PHARMACEUTICALS ULC | QUETIAPINE XR/50MG | DIN 02417359 | Tablet | QUETIAPINE (QUETIAPINE FUMARATE) 50 mg | M2213000, M2213001, M2215146, M2214004, M2214005 |
| SIVEM PHARMACEUTICALS ULC | QUETIAPINE XR/150MG | DIN 02417367 | Tablet | QUETIAPINE (QUETIAPINE FUMARATE) 150 mg | M2214685, M2214686, M2214687 |
| SIVEM PHARMACEUTICALS ULC | QUETIAPINE XR/200MG | DIN 02417375 | Tablet | QUETIAPINE (QUETIAPINE FUMARATE) 200 mg | M2214012, M2214013, M2214014 |
| SIVEM PHARMACEUTICALS ULC | QUETIAPINE XR/300MG | DIN 02417383 | Tablet | QUETIAPINE (QUETIAPINE FUMARATE) 300 mg | M2214016, M2214017, M2214018 |
| SIVEM PHARMACEUTICALS ULC | QUETIAPINE XR/400MG | DIN 02417391 | Tablet | QUETIAPINE (QUETIAPINE FUMARATE) 400 mg | M2214020 |
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.
- 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: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
SIVEM PHARMACEUTICALS ULC
4705 Dobrin
Saint-Laurent, QC
H4R 2P7
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type I
Identification number
RA-76803
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