Recall of Cannabis for Medical Purposes - Peace Naturals Project Inc.

Starting date: May 18, 2017 Type of communication: Drug Recall Subcategory: Drugs Hazard classification: Type III Source of recall: Health Canada Issue: Undeclared Substance Audience: General Public Identification number: RA-63360

Introduction

On May 18, 2017, Peace Naturals Project Inc., a licensed producer of cannabis for medical purposes located in Ontario, began a voluntary Type III recall of 74 lots of dried marijuana and cannabis oil that were produced between November 23, 2015 and January 06, 2017. The affected lot numbers are found below.

Reason

Following an unannounced inspection by Health Canada at the Peace Naturals Project Inc. site in March 2017 to conduct random sampling of cannabis products, test result of one of the two samples of leaves collected tested positive for piperonyl butoxide at low level concentration of 0.78 parts per million (ppm). Peace Naturals Project Inc. undertook further testing on various products at their site which indicated the presence of low levels of piperonyl butoxide in dried marijuana, cannabis oil and marijuana plants. As a result, on May 18, 2017, Peace Naturals Project Inc. initiated a voluntary Type III recall for products sold between November 26, 2015 to March 13, 2017.

A Type III recall refers to a situation in which the use of, or exposure to a product is not likely to cause any adverse health consequences.

Piperonyl butoxide is a synergist that is combined with pesticides to increase their effectiveness. Piperonyl butoxide is not found in the seventeen pest control products that are authorized for use on cannabis plants under the Pest Control Products Act. Piperonyl butoxide is found in pest control products that are approved for use in food production. All tested lots did not exceed any of the levels permitted in food production for piperonyl butoxide.

Health Canada has received one adverse reaction report related to Peace Naturals Project Inc.'s products sold affected by the recall. Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Peace Naturals Project Inc., at the following number 1-888-647-3223.

Affected products

Dried marijuana and/or cannabis oil

DIN, NPN, DIN-HIM Not Applicable Dosage form Not Applicable Not Applicable Strength Various Lot or serial number The following lots are classified under the Type III recall initiated on May 18, 2017. 225

227

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0021E Companies Recalling Firm Peace Naturals Project Inc.

Ontario

CANADA

Tel: 1-888-647-3223 Marketing Authorization Holder Not Applicable

Media enquiries

Health Canada

(613) 957-2983