Public recall detail

QUETIAPINE XR : Affected lots may exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP)

2025-01-07

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Recall Safety notice
Quick summary

Quick summary: QUETIAPINE XR : Affected lots may exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP). Date: 2025-01-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: QUETIAPINE XR : Affected lots may exceed the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP). Date: 2025-01-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandQUETIAPINE XR, SIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR
IssueHealth products - Product quality
Recall classType I
IdentificationRA-76803

Affected products

BrandSIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR/50MG
DIN / NPN / authorizationDIN 02417359
Dosage formTablet
StrengthQUETIAPINE (QUETIAPINE FUMARATE) 50 mg
LotM2213000, M2213001, M2215146, M2214004, M2214005
BrandSIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR/150MG
DIN / NPN / authorizationDIN 02417367
Dosage formTablet
StrengthQUETIAPINE (QUETIAPINE FUMARATE) 150 mg
LotM2214685, M2214686, M2214687
BrandSIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR/200MG
DIN / NPN / authorizationDIN 02417375
Dosage formTablet
StrengthQUETIAPINE (QUETIAPINE FUMARATE) 200 mg
LotM2214012, M2214013, M2214014
BrandSIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR/300MG
DIN / NPN / authorizationDIN 02417383
Dosage formTablet
StrengthQUETIAPINE (QUETIAPINE FUMARATE) 300 mg
LotM2214016, M2214017, M2214018
BrandSIVEM PHARMACEUTICALS ULC
ProductQUETIAPINE XR/400MG
DIN / NPN / authorizationDIN 02417391
Dosage formTablet
StrengthQUETIAPINE (QUETIAPINE FUMARATE) 400 mg
LotM2214020

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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesSIVEM PHARMACEUTICALS ULC 4705 Dobrin Saint-Laurent, QC H4R 2P7
DistributionNational
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-76803
Background{}
CompaniesSIVEM PHARMACEUTICALS ULC 4705 Dobrin Saint-Laurent, QC H4R 2P7
AudiencesGeneral public Healthcare Industry
Source updated2025-01-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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