Public recall detail

PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine

2025-06-30

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Recall Safety notice
Quick summary

Quick summary: PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine. Date: 2025-06-30.

Recommended action

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

Recall details

Quick summary: PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine. Date: 2025-06-30.

Official details

Affected product details

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

BrandPro Doc Limitée
ProductPRO-Fluoxetine 10 mg capsule
IssueHealth products - Product quality
Recall classType I
IdentificationRA-77659

Affected products

BrandPro Doc Limitée
ProductPRO-Fluoxetine 10 mg capsule
DIN / NPN / authorizationDIN 02314991
Dosage formCapsule
StrengthFluoxetine hydrochloride 10 mg
Lot651194, 656543, 658509, 659876

Issue

Affected lots may exceed the interim acceptable intake limit for N-nitroso-fluoxetine.

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
CompaniesPro Doc Limitée 2925 Boulevard Industriel Laval Quebec H7L 3W9 Canada
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-77659
Background{}
CompaniesPro Doc Limitée 2925 Boulevard Industriel Laval Quebec H7L 3W9 Canada
AudiencesGeneral public Healthcare Industry
Source updated2025-06-30

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

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