DRUG RECALL – TYPE I – URGENT Dextrose 5% Injection 250ml
July 13, 2020
Date: July 11th, 2020
Risk Classification: Type I Recall * URGENT *
Drug: Dextrose 5% Injection, Mfr.Standard
Product Code: K925511
DIN: 02403536
Distributed Lots: 14NB7328
Expiry Date: 01/2022
Fresenius Kabi Canada would like to inform you of our decision to recall Dextrose 5% Injection Lot: 14NB7328 due to the possibility of leaking bags. Health Canada has been informed of this issue and is aware of the recall proceedings.
Please examine your inventory immediately to determine if you have any of the product and affected lot numbers on hand. If yes, discontinue use immediately. Please complete the Customer Reply Form provided as soon as possible.
Affected units should be returned to the following site:
Fresenius Kabi Canada Ltd.
c/o Accuristix
109 Summerlea Road
Brampton, ON L6T 4P6
For pick-up of product to be returned, please contact ATS at 1-877-694-4454 and utilize Account Number 4005154 for return of the product.
Please ensure within your organization that every user of the concerned products and all other relevant persons or entities where the concerned products have been transferred are informed about this letter and the actions as described herein.
If you experience an adverse reaction with respect to this occurrence, please contact Fresenius Kabi Canada Vigilance department and identify the product and lot associated with the incident. Adverse reactions experienced with the use of this product should be reported to Fresenius Kabi Canada at Canada_Vigilance@fresenius-kabi.com . Quality concerns can be reported to Fresenius Kabi Complaints department at Canada_Product_Complaints@Fresenius-Kabi.com.
Please complete the attached Customer Reply Form to confirm that you have received this letter and return it to Fresenius Kabi Canada via the fax number or email address provided on the form.
Fresenius Kabi is committed to providing you with the highest level of service, product quality and reliability. We apologize for any inconvenience this has caused and we appreciate your attention to this matter.
Regards,
Anabela Costa
Director, Quality
Fresenius Kabi Canada Ltd.