Public recall detail

SALOFALK 500mg: tablets may show black spots due to the oxidation of the active ingredient.

2025-04-24

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Recall Safety notice
Quick summary

Quick summary: SALOFALK 500mg: tablets may show black spots due to the oxidation of the active ingredient.. Date: 2025-04-24.

Recommended action

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

Recall details

Quick summary: SALOFALK 500mg: tablets may show black spots due to the oxidation of the active ingredient.. Date: 2025-04-24.

Official details

Affected product details

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

BrandAbbvie
ProductSALOFALK 500mg
IssueHealth products - Product quality
Recall classType II
IdentificationRA-77329

Affected products

BrandAbbvie
ProductSALOFALK 500mg
DIN / NPN / authorizationDIN 02112787
Dosage formTablet (Delayed-Release)
StrengthMESALAZINE 500mg
Lot247646A & 247647A

Issue

Some tablets in the affected batches may show black spots due to the oxidation of the active ingredient.

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
CompaniesAbbVie Corporation 8401 Trans-Canada Highway, St-Laurent, QC, H4S 1Z1
DistributionNational
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77329
Background{}
CompaniesAbbVie Corporation 8401 Trans-Canada Highway, St-Laurent, QC, H4S 1Z1
AudiencesGeneral public Healthcare Industry
Source updated2025-04-24

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

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