Public recall detail

Sandoz Fesoterodine Fumarate 8 mg tablet; Out-of-specification (diester impurity)

2024-05-16

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Recall Safety notice
Quick summary

Quick summary: Sandoz Fesoterodine Fumarate 8 mg tablet; Out-of-specification (diester impurity). Date: 2024-05-16.

Recommended action

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

Recall details

Quick summary: Sandoz Fesoterodine Fumarate 8 mg tablet; Out-of-specification (diester impurity). Date: 2024-05-16.

Official details

Affected product details

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

BrandSandoz Canada, Sandoz
ProductSandoz Fesoterodine Fumarate 8 mg tablet
IssueHealth products - Product quality
Recall classType II
IdentificationRA-75528

Affected products

BrandSandoz
ProductSandoz Fesoterodine Fumarate 8 mg tablet
DIN / NPN / authorizationDIN 02521776
Dosage formTablet (Extended-Release)
StrengthFesoterodine fumarate 8 mg
Lot2205009088, 2205010476, 2205011235

Issue

The diester impurity is out of specification in the affected lots.

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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesSandoz Canada Incorporated 110 Rue de Lauzon, Boucherville, QC, Canada J4B 1E6
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75528
Background{}
CompaniesSandoz Canada Incorporated 110 Rue de Lauzon, Boucherville, QC, Canada J4B 1E6
AudiencesGeneral public Healthcare Industry
Source updated2024-05-16

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

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