Taro Pharmaceuticals Canada Inc.'s Voluntary Recall of Docusate Sodium Capsules

Starting date:

June 3, 2011

Posting date:

June 3, 2011

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110005082

• 
  Issue
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Affected products
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

Taro Pharmaceuticals Canada Inc., in consultation with Health Canada, is voluntarily recalling "Docusate Sodium Capsules USP, 100 mg" (Lot # 31040225) from the Canadian market due to possible contamination with the bacterial organism cronobacter (enterobacter) sakazakii.

Issue

Cronobacter (enterobacter) sakazakii is a bacteria that is a rare cause of serious or life-threatening infections, including meningitis and bloodstream infections, particularly in premature infants. Other vulnerable individuals include the elderly and those with weakened immune systems.

What you should do

• Consumers should speak to their healthcare practitioner if they or any of their family members have used this product.
• Taro Pharmaceuticals Canada Inc. is advising consumers to discontinue use of Docusate Sodium Capsules USP, 100 mg" (Lot # 31040225).
• Report any adverse reaction potentially related to these products to Health Canada (see below).
• Media and consumers should contact Taro Pharmaceuticals Canada Inc. at 1-800-268-1975 for more information.

Who is affected

Canadians who have purchased or used "Docusate Sodium Capsules USP, 100 mg" (Lot # 31040225)

Background

Taro Pharmaceuticals Canada Inc. has discontinued distribution of "Docusate Sodium Capsules USP, 100 mg" (Lot # 31040225) and is following-up with their wholesalers and retailers.

Affected products

Report health or safety concerns

To report a suspected adverse reaction to these or other health products, please contact Heath 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:

• Facsimile: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  
  Marketed Health Products Directorate
  
  Ottawa, ON, Address Locator 0701E
  
  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 is monitoring the recall of "Docusate Sodium Capsules USP, 100 mg" (Lot # 31040225) from the Canadian market. Should any new information be identified, Health Canada will continue to provide an update to Canadians.

It is important to note that to date, Health Canada has not received any reports of adverse reactions in Canada associated with the use of Taro Pharmaceuticals Canada Inc's. Docusate Sodium Capsules USP, 100 mg and contamination.