Public recall detail

Heparin sodium in 5% Dextrose injection; Out of specification

2023-05-11

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Recall Safety notice
Quick summary

Quick summary: Heparin sodium in 5% Dextrose injection; Out of specification. Date: 2023-05-11.

Recommended action

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

Recall details

Quick summary: Heparin sodium in 5% Dextrose injection; Out of specification. Date: 2023-05-11.

Official details

Affected product details

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

BrandB. Braun Medical Inc
ProductHeparin Sodium in 5% Dextrose injection 25000 unit / 500 mL
IssueHealth products - Product quality
Recall classType II
IdentificationRA-73658

Affected products

BrandB. Braun Medical Inc
ProductHeparin Sodium in 5% Dextrose injection 25000 unit / 500 mL
DIN / NPN / authorizationDIN 01935941
Dosage formSolution
StrengthCitric acid 93 mg / 100mL Dextrose 5 g / 100mL Heparin sodium 5000 unit / 100mL Sodium phosphate dibasic 410 mg / 100mL
LotJ2E209N

Issue

The Anti-Factor Ila potency is out of specification in the affected lot.

What you should do

  • Verify if your product is affected.
  • 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
CompaniesB. Braun Medical Inc 2000 Ellesmere Road, Unit 16, Scarborough ON M1H 2W4 Canada
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73658
Background{}
CompaniesB. Braun Medical Inc 2000 Ellesmere Road, Unit 16, Scarborough ON M1H 2W4 Canada
AudiencesGeneral public Healthcare Industry
Source updated2023-05-11

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

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