Health product recall

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

  1. Verify if your product is affected.
  2. Contact the recalling firm if you have any questions about the recall.
  3. Report any health product related side effects to Health Canada.
  4. 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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