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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
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-60098

Audience

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.

Key messages

  • 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.

        

Issue

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.

Products affected

Products affected
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

Background information

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
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652

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
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

Original signed by

Vratislav Hadrava M.D., Ph.D.
Vice President & Medical Director
Pfizer Canada Inc.

Images

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For more information

The 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.