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Imipenem and Cilastatin for Injection 500 mg/500 mg Single-Dose Vials - Incorrect Labelling Information
- Starting date:
- September 6, 2016
- Posting date:
- September 6, 2016
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals, General Public
- Identification number:
Healthcare professionals including physicians, pharmacists, pharmacy technicians and nurses in hospitals. Please distribute this communication to the appropriate personnel within your facility who are using this product.
Retail pharmacists that reconstitute and dilute the product for ambulatory care purposes and healthcare professionals who may reconstitute and dilute the product in a home care setting for patient administration.
- The multi-vial carton of Imipenem and Cilastatin for Injection, 500 mg/500 mg, has incorrect information regarding the final diluted concentration on the outer side panel. It indicates the diluted concentration is 2.5 mg/mL instead of 5 mg/mL when prepared as per the instructions in the package insert. This incorrect information could lead to a potential dosing error.
- Healthcare professionals should consult the package insert for the proper reconstitution and dilution instructions.
Imipenem and Cilastatin Injection 500 mg/500 mg single-dose vials have a labelling text error on the outer side panel of the multi-vial carton. It indicates that the reconstituted product contains 2.5 mg/mL of imipenem and cilastatin (see image below of the incorrect side panel of the carton). In fact, the correct concentration after reconstitution and dilution is 5 mg/mL. This labelling error could possibly result in a patient receiving a double dose of imipenem/cilastatin.
The strength of the product displayed on the front panel of the carton, the vial label and the package insert as well as the reconstitution and dilution instructions in the package insert are correct.
|PRODUCT DESCRIPTION||DIN||SIZE||Product Code||UPC CODE||LOT #|
|Imipenem and Cilastatin for Injection 500 mg /500 mg single-dose vials||02357437||10 x 500 mg||03507001||(01)18821353507003||615F001, 615F002|
Imipenem and Cilastatin for Injection is an antibiotic used in various serious bacterial infections. This product is not for direct infusion but must be reconstituted and further diluted before use.
Who is affected
Advice for Consumers
Patients receiving this product in a home care setting should consult with their healthcare professional to confirm that they are receiving the correct dose of their medication.
Information for Healthcare professionals
Imipenem and Cilastatin for Injection should be reconstituted and diluted according to the instructions found in the package insert.
Central nervous system (CNS) adverse experiences such as myoclonic activity, confusional states, or seizures have been reported with imipenem and cilastatin especially when recommended dosages based on renal function and body weight were exceeded. These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or who have compromised renal function. However, there were rare reports in which there was no recognized or documented underlying CNS disorder.
Action taken by Health Canada
Health Canada is communicating this important safety information to healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect e-Notice email notification system. Health Canada is also monitoring the implementation of necessary corrective and preventive actions.
Report health or safety concerns
Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of dosing error or other serious or unexpected side effects in patients receiving Imipenem and Cilastatin for Injection 500 mg/500 mg should be reported to Hospira Healthcare Corporation, a Pfizer company, or Health Canada.
Hospira Healthcare Corporation, a Pfizer Company
17300 Trans-Canada Highway
To correct your mailing address or fax number, contact Hospira Healthcare Corporation.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Regulatory Operations and Regions Branch
Original signed by
Vratislav Hadrava M.D., Ph.D.
Vice President & Medical Director
Pfizer Canada Inc.
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For more informationThe manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.
- Date modified: