Public recall detail

Sanis Health Duloxetine 60 mg Capsule; Exceeds acceptable interim intake limit for N-nitroso-duloxetine (NDLX)

2024-05-16

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Recall Safety notice
Quick summary

Quick summary: Sanis Health Duloxetine 60 mg Capsule; Exceeds acceptable interim intake limit for N-nitroso-duloxetine (NDLX). 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: Sanis Health Duloxetine 60 mg Capsule; Exceeds acceptable interim intake limit for N-nitroso-duloxetine (NDLX). 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.

BrandSanis Health Inc., Sanis Health
ProductSanis Health Duloxetine 60 mg Capsule
IssueHealth products - Product quality
Recall classType I
IdentificationRA-75527

Affected products

BrandSanis Health
ProductDuloxetine 60 mg Capsule
DIN / NPN / authorizationDIN 02490897
Dosage formCapsule (Delayed Release)
StrengthDuloxetine Hydrochloride 60 mg
Lot644182

Issue

The affected lot exceed the interim acceptable intake limit for N-nitroso-duloxetine (NDLX).

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
CompaniesSanis Health Inc. 243 Consumers Road, Toronto Ontario M2J 4W8
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75527
Background{}
CompaniesSanis Health Inc. 243 Consumers Road, Toronto Ontario M2J 4W8
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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