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YERVOY 200 mg/40 mL (5 mg/mL) (Ipilimumab for injection), single-use vial - Recall of 2 Lots Due to Cracked Vials - Notice to Hospitals

Starting date:
October 18, 2014
Posting date:
October 18, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-41861

This is duplicated text of a letter from Bristol-Myers Squibb Canada. 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 YERVOY 200 mg/40 mL(5 mg/mL) (Ipilimumab for injection), single-use vial

October 18, 2014

Dear Healthcare Professional:

Please distribute to relevant Departments of Pharmacy, Oncology, Oncology clinics, Internal Medicine, Nursing, and other Departments as required, and other involved professional staff and post this NOTICE in your institution.

Subject: Recall of YERVOY (ipilimumab for injection) 200 mg/40 mL vial DIN 02379384 – Lots 924741 and 924041

Bristol Myers Squibb Canada is initiating a voluntary recall of the YERVOY 200 mg/40 mL (5 mg/mL) (Ipilimumab for injection) single-use vial lots 924741 and 924041 as a precautionary measure due to two (2) confirmed complaints of cracked vials received by Bristol-Myers Squibb. The reason for this recall is that a cracked vial may compromise the sterility of the product and/or introduce small glass particles into the vial. The lots were distributed between April 14, 2014 to September 17, 2014.  The recall is to the dispensing level (hospital and pharmacy) and is being conducted with the knowledge of Health Canada.

  • There is a possibility of the presence of some cracked vials in 2 lots of YERVOY (for injection) 200 mg/40 mL vials. A cracked vial may compromise the sterility of the product and/or introduce small glass particles into the vial.
  • Physicians should remain vigilant to the possibility of serious events in patients having received YERVOY.

Although there is a theoretical high risk to patients with respect to loss of sterility, the likelihood of such occurrence is extremely low due to the fact that the safety assessment conducted did not find any adverse reports potentially related to cracked vials. In addition, the product label has clear instructions on how to inspect the vial during preparation which will prevent inadvertent use of a vial with a crack and the inline filter used during infusion will prevent small glass particles (if present) from getting into the patient IV line.

YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.1

The product impacted is Yervoy:
STRENGTH DIN NO. LIST NO. LOT NO. EXPIRY DATE
200 mg/vial 02379384 1289111 924741 August 2015
200 mg/vial 02379384 1289111 924041 August 2015

Managing marketed health product-related adverse reactions depends on healthcare 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 YERVOY 200 mg/40 mL vials from Lots 924741 and 924041 should be reported to Bristol-Myers Squibb Canada or Health Canada at the following addresses:

Bristol-Myers Squibb Canada, Medical Services
2344 Alfred-Nobel, suite 300
Montréal, Québec
H4S 0A4
Tel :  866-463-6267

To correct your mailing address or fax number, contact Bristol-Myers Squibb Canada, Medica Services.

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 Product and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

We do not expect this recall to impact the supply of YERVOY.

We sincerely apologize for any inconvenience this may cause and appreciate your prompt attention to this matter.

If you have any questions regarding this recall, please contact Customer Services at 1-800-267-0005 (8:30 a.m. to 5:00 p.m. Eastern Standard Time). For medical queries, please call Medical Services at 1-866-463-6267.

original signed by

Dr. Babak Abbaszadeh, MD, MBA
Vice-President Medical Affairs
Reference

References:

1 Yervoy (ipilimumab). Canadian Product Monograph. Bristol-Myers Squibb Canada, September 10, 2014.

For more information

The manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted 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.