Date: May 16th, 2020
Risk Classification: Type I Recall * URGENT *
Drug: Penicillin G Sodium for Injection, USP
Product Code: PF170002
Distributed Lots: 305609, 305610, 305873
Fresenius Kabi Canada would like to inform you of our decision to recall three (3) lots of Penicillin G Sodium for Injection Lots: 305609, 305610 and 305873 due to the possibility of the presence of glass defects on the vials. 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.
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.
Fresenius Kabi would also like to advise that supply interruptions may result due to the issuance of this recall. Please reach out to Fresenius Kabi Customer Service for the availability of alternate Penicillin G Sodium for Injection presentations. In order to mitigate supply shortages at your site, Fresenius Kabi suggests that customers consider the following alternate presentations, not affected by this recall, which are available for the product:
Fresenius Kabi is working to bring unaffected product to the market in order to mitigate a potential for shortage.
If you experience an adverse reaction with respect to this occurrence, please contact Fresenius Kabi Canada Medical Information 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_Medinfo@fresenius-kabi.com. Quality problems experienced 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.
Fresenius Kabi Canada Ltd.