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Dacarbazine for Injection 600 mg/vial, BP - Discoloration After Reconstitution of Vials - Notice to Hospitals

Starting date:
September 9, 2014
Posting date:
September 9, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-41345

This is duplicated text of a letter from Hospira Healthcare Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Dacarbazine for Injection 600 mg/vial, BP

September 9, 2014

Dear Healthcare Professional and Director of Pharmacy,

Please distribute to the relevant Departments (Pharmacy, Emergency Medicine, Geriatrics, Internal Medicine, Nursing, Intensive Care, Oncology, Oncology Clinics and/or other Departments as required), other involved professional staff, and post this NOTICE in all relevant areas of your institution.

Subject: Discoloration after reconstitution of vials of Hospira Dacarbazine for Injection 600 mg/vial, BP (DIN 02241445), lot A032228AA, lot A042228AA and lot B032228AA

Following the receipt of customer reports,  Hospira Healthcare Corporation, in consultation with Health Canada, is  informing  Healthcare professionals that some vials of Dacarbazine for Injection 600 mg/vial, BP  may turn pink immediately after reconstitution or during storage of reconstituted product. Dacarbazine for Injection is indicated as palliative therapy for metastatic malignant melanoma.

  • Pink discoloration of the reconstituted solution has been observed immediately after reconstitution in some vials, or after storing for 24 hours at 2- 8 °C. The discoloration is due to degradation products whose impact on the potency of the drug is unknown.
  • Healthcare professionals are advised to inspect the reconstituted solution for clarity and discoloration against a white panel prior to administration. Vials that exhibit pink discoloration (faint pink to maroon) upon reconstitution should not be used and should be returned to Hospira Healthcare Corporation, or the Hospira Distribution Network.
  • If not discoloured, the reconstituted solution should be used immediately without subsequent storage.

The reconstituted solution should appear clear and colorless. To return product that exhibits pink discoloration, please contact Hospira Healthcare Corporation at: 1-866-488-6088 Option 6, ProductComplaintsCA@hospira.ca. A Return Goods Authorization (RGA) number will be issued to facilitate the return of your products.

The root cause is currently being investigated by Hospira Healthcare Corporation. To date, there have been no adverse events associated with this issue.

The product impacted is:

Description

Dacarbazine for Injection 600 mg/vial, BP

DIN

02241445

Lot

A032228AA
A042228AA
B032228AA
 
Exp. Date
 
2015-11-30 
2015-12-31
2016-03-31

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-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving Dacarbazine for Injection 600 mg/vial, BP should continue to be reported to Hospira Healthcare Corporation or Health Canada.

Hospira Healthcare Corporation
1111 Dr.-Fredrerik-Philips, Suite 600
Saint-Laurent (Quebec) H4M 2X6

To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
Email: ProductcomplaintsCA@hospira.com

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, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

original signed by

Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation

For more information

The manufacturer advised Health Canada of the risk associated with this health product's quality. 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.