Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Sandoz Liquid Injectable Products - Potential Presence of Particulate Matter in Glass Vials - For Health Professionals

Starting date:
January 10, 2014
Posting date:
January 13, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-37519

This is duplicated text of a letter from Sandoz Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Sandoz Injectable Products Containing Liquid in Glass Vials (≤30 mL)

January 10, 2014

Dear Healthcare Professional,

Subject: Safety Information Regarding Sandoz Liquid Injectable Products in Glass Vials (≤30 mL)

Sandoz Canada Inc., in consultation with Health Canada, would like to inform you of a situation related to glass vials of 30 mL and less that have been used in the manufacturing of a number of Sandoz Injectable products currently being distributed on the Canadian market. The potential presence of particulate matter, determined to be inert carbon related to the vial manufacturing process, has been reported for certain products.

Sandoz Canada Inc. recently issued two communications to the attention of Healthcare Professionals to notify them about precautions to be taken with regard to the use of Phosphate Injectable ProductsFootnote 1 and Phenytoin Sodium Injection USPFootnote 2. For products identified in these notices, although no particulate matter has been reported for any lot released onto the Canadian market, and all lots met all standards for particulate matter prior to release, the possible presence of particulate matter in these products could not be excluded. Following an investigation, Sandoz Canada Inc. implemented appropriate corrective and preventive actions to address this issue and is in the process of transitioning to production of their injectable products using unaffected glass vials.

For all other Sandoz liquid injectable products contained in glass vials (≤30 mL) (other than Phosphate Injectable Products and Phenytoin Sodium Injection USP), the investigation concluded that the presence of particulate matter related to this issue is highly unlikely. Nevertheless, Sandoz Canada Inc. would like to remind you of the following precautionary measures:

  • As per standard recommendations for all injectable products, carefully inspect all Sandoz liquid Injectable products before administration (prior to and following dilution, where applicable).
  • Should particulate matter be observed, do not administer.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of particulate matter observed in a Sandoz Injectable Product should be reported to Sandoz Canada Inc.

Sandoz Canada Inc.
145 Jules Léger
Bouchervillle, Quebec, Canada
J4B 7K8
Tel: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221

To correct your mailing address or fax number, contact Sandoz Canada 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, please contact Health Canada at:
Health Products and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

If you have questions regarding the above information, please contact our Drug Information Department at 1-800-343-8839 (4636). 

Sincerely,

original signed by

Michèle Théberge
Vice-President, Quality Unit

Len Arsenault
Vice-President, Scientific Affairs