GlaxoSmithKline Voluntarily Recalling Emo-Cort 2.5%

Starting date:

October 29, 2010

Posting date:

October 29, 2010

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination, Product Safety

Audience:

General Public

Identification number:

RA-110003885

• Reason
• What you should do
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing

Health Canada is informing Canadians that GlaxoSmithKline (GSK) has begun to voluntarily recall, LOT# 5R6 of their product, Emo-Cort 2.5% Lotion currently available on the Canadian market. GSK is requesting that wholesalers, pharmacies and hospitals immediately stop sale of this lot. Emo-Cort (hydrocortisone) 2.5% Lotion is used in the treatment of eczema, dermatitis and other skin irritations.

Reason

This recall comes as a result of a consumer complaint to GSK regarding a brown substance in the product. As a result of GSK's testing of several LOT# 5R6 samples, the presence of mould contamination has been identified. There is a potential risk of local or more widespread infection from the mould contamination in those Canadians with weakened immune systems. In light of this information, GSK, as a precautionary measure, is putting all its Emo-Cort products at the manufacturing facility on hold pending their investigation.

What you should do

Canadians may wish to consult with their healthcare practitioner if they have used this product or about the appropriateness of alternatives currently authorized and available on the Canadian market.

Background

GSK had recently recalled a similar product, Emo-Cort 1%, lot# 12R7, from the Canadian market due to mould contamination. For more information on this recall, please visit Health Canada's web site.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• E-mail: CanadaVigilance@hc-sc.gc.ca
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada will continue monitoring the safety of all health products on the Canadian market, including those sold by GSK and will inform Canadians and take appropriate action if new safety information arises.

Health Canada reminds Canadians who have concerns about these products that they may wish to also contact GSK at 1-800-387-7374.