SteriMax-Vancomycin Hydrochloride Injection USP - French Labelling Error for Reconstituted Solution

Starting date:
July 6, 2015
Posting date:
July 6, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
Healthcare Professionals, General Public
Identification number:
RA-54072

Audience

Health care professionals working in hospitals, clinics and pharmacies.

Key messages

  • A typographical error has been identified on one lot (Lot# BK112A14) of SteriMax Vancomycin Hydrochloride for Injection USP, 1g/vial, DIN # 02396386.
  • This error is only displayed on the French text of the secondary (outer) carton’s reconstitution instructions of the product where it presents the recommended volume for reconstitution to be 20.6 mg/mL instead of 20.6 mL to yield a final concentration of 50 mg/mL.
  • Although unlikely, there is a potential for a dosing error if only the reconstitution information on the secondary (outer) carton of the French text is used.
  • Health care professionals are requested to follow the information found on the vial label and package insert which correctly indicates the dosing information: “20.6 mL (50 mg/mL)”.

               

Issue

A typographical error was identified on one lot (Lot# BK112A14) of SteriMax Vancomycin Hydrochloride for Injection USP, 1g/vial, (DIN# 02396386). Although unlikely, there is a potential for a dosing error (i.e. final dose greater than 2X the intended dose) to occur if the reconstitution information on the secondary (outer) carton of the French text is used.

Products affected

The product impacted is:
Product DIN No. Lot No. Distribution Date Exp. Date
SteriMax - Vancomycin Hydrochloride Injection USP, 1g/vial 02396386 BK112A14 January 23, 2015 to
June 26, 2015
June 2016

Background information

Vancomycin Hydrochloride Injection USP is indicated for the treatment of severe or life-threatening staphylococcal infections in patients who cannot receive or have failed to respond to penicillins or cephalosporins or who have infections with staphylococci resistant to other antibiotics, including methicillin.

A typographical error is found on one lot (Lot# BK112A14) of SteriMax Vancomycin Hydrochloride for Injection USP, 1g/vial, (DIN# 02396386). This error is displayed on the French text of the secondary (outer) carton of the product, under the section Réconstitution as shown in italics below:

Error: Donne 20.6 mg/mL (50mg/mL)
Label should read as follows: Donne 20.6 mL (50mg/mL)

The text on the English label of the secondary (outer) carton for SteriMax Vancomycin Hydrochloride for Injection USP, 1g/vial, has the correct information.

The English and French information is correct in the Reconstitution table, on the vial label and in the packaging insert of this lot.

There are no concerns with the quality of the product.

Who is affected

Information for consumers

This product is generally administered by health care professionals, in a hospital setting. Vancomycin Hydrochloride Injection is used to treat serious bacterial infections.

The risk of a dosing error is considered unlikely. Consumers with any questions about their Vancomycin treatment should contact their health care professional for more information.

Information for health care professionals

Health care professionals are requested to follow the information found on the vial label and package insert which correctly indicates the dosing information, “20.6 ml (50 mg/mL)”.

Action taken by Health Canada

Health Canada is communicating this information to health care professionals and to the public through its MedEffect Canada website. 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 health care professionals and consumers reporting them. Any health product-related concerns due to this labelling error for SteriMax Vancomycin Hydrochloride Injection USP, 1g/vial should be reported to SteriMax Inc. or Health Canada.

SteriMax Inc.
2770 Portland Drive, Oakville, ON, L6H 6R4
Phone number: 1-800-881-3550, Fax number: 1-877-546-7667

To correct your mailing address or fax number, contact SteriMax Inc.

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:

Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-237-9675
Fax: 1-613-946-5636

Original signed by

Nazia Dar
Senior Director-Quality Affairs,
SteriMax Inc.

Images

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For more information

Through surveillance, the manufacturer identified a risk associated with the product and has submitted to Health Canada an update to its product label to reflect the findings. The label changes have been reviewed and approved by Health Canada. A comprehensive internal signal assessment was not required for this issue, and therefore a Summary Safety Review is not available.