Appendix B: Drug, natural health product and biocide recall guide (GUI-0039)

On this page

• When to use the drug recall communication template
• How to complete this template

When to use the drug recall communication template

This template is an example of a drug recall communication. Use this template when you:

• have initiated a drug, natural health product or biocide recall
• are required to inform consignees that will be affected by the recall

How to complete this template

The template is composed of 2 documents:

1. template drug, natural health product or biocide recall letter
2. product return form

Drug, natural health product or biocide recall letter

To complete the drug, natural health product or biocide recall letter, refer to the text that appears in bold and in brackets. Modify or remove text in bold before sending your letter. Refer to instructions in brackets to help you fill in the information that applies to your recall.

For Type I and II drug, natural health product or biocide product hazards, mark the recall notification as urgent in bold, red type using all capital letters.

Product return form

Once you have completed the drug recall letter, fill out the product return form. Modify and then delete text in bold. To include clear instructions for how to return required information, be sure to fill in the:

• “return by” date
• name of the person in charge of receiving returns (for example, your customer service centre)
• your establishment’s fax number
• your establishment’s telephone number
• method of return shipment (for example, courier)
• your mailing address for returns

Sample drug, natural health product or biocide recall letter

Urgent drug recall

yyyy-mm-dd

Re: Product name, size, lot number(s), expiry date

(Include any other relevant descriptive information, as needed.)

Dear Name of consignee,

A drug product you have received or sold is being recalled from the Canadian market.

(Specify the hazard associated with the product. State whether the recall is Type I, II or III as well as the reason for the recall.)

For example: “We are initiating this recall due to an out-of-specification stability test result on the potency assay. The lot met specifications at the time of release. There are (no) adverse reaction reports or complaints associated with the potency assay related to this lot. The risk classification associated with this product is Type III. This is defined as a situation in which the use of, or exposure to, the product is not likely to cause adverse health consequences.”

Due to this recall, you are required to:

• immediately stop all sale or distribution of these lot numbers
• advise your consignees of this recall
• Consignees must return the product with these lot numbers to you.
• immediately conduct an inventory assessment. Fax or email the attached Product Return Form to the attention of: Name, fax number and email address for the appropriate customer response centre
• return all stock for the above listed lot(s) to: Your address

Please complete these actions by (specify a timeframe for the consignee to respond to the notification). We have notified Health Canada about this recall.

Thank you for your cooperation and assistance. Please do not hesitate to contact us if you need further information.

Sincerely,

• Name of contact
• Company name
• Mailing address
• Phone number
• Email address
• Attachment: Product Return Form

Sample Product Return Form

RE: Drug recall

Please return by Month-Day-Year to Contact person, Customer Response Centre, Name of establishment.

Fax number: xxx-xxx-xxxx
Telephone number: xxx-xxx-xxxx
Email: Email address
Indicate the amount of product per lot you currently have in stock. If you do not have stock in your possession, mark “0” for each lot. We will follow up with you if we do not receive a reply by: yyyy-mm-dd.

Client information
Name:	Address:
Product details
Product number:
Product name:
Lot number:	Quantity in stock:
Lot number:	Quantity in stock:
Lot number:	Quantity in stock:
Lot number:	Quantity in stock:
Authorized signature
Signature of authorized person:	Date (yyyy-mm-dd):
Printed name:

Return all products with these lots, along with a copy of this form, by (insert method of return shipment, such as Purolator Collect) to:

Your return address
Attention: Person in charge, Customer Response Centre