Public recall detail

PMS-Montelukast: An impurity is out of trend

2023-08-09

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Recall Safety notice
Quick summary

Quick summary: PMS-Montelukast: An impurity is out of trend. Date: 2023-08-09.

Recommended action

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

Recall details

Quick summary: PMS-Montelukast: An impurity is out of trend. Date: 2023-08-09.

Official details

Affected product details

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

BrandPMS-Montelukast
ProductPMS-Montelukast
IssueHealth products - Product quality
Recall classType II
IdentificationRA-74083

Affected products

BrandPMS-Montelukast
ProductPMS-Montelukast
DIN / NPN / authorizationDIN 02354977
Dosage formChewable tablet
StrengthMontelukast (Montelukast Sodium) 4 mg
Lot644028

Issue

An impurity is out of trend in the affected batch.

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
CompaniesPHARMASCIENCE INC 6111 Royalmount Ave, Montreal Quebec, H4P 2T4
DistributionNational
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74083
Background{}
CompaniesPHARMASCIENCE INC 6111 Royalmount Ave, Montreal Quebec, H4P 2T4
AudiencesGeneral public Healthcare Industry
Source updated2023-08-09

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

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