Recall of Cannabis for Medical Purposes - Aurora Cannabis Enterprises Inc.

Starting date: November 16, 2017 Posting date: November 16, 2017 Type of communication: Drug Recall Subcategory: Drugs Hazard classification: Type II Source of recall: Health Canada Issue: Labelling and Packaging Audience: General Public Identification number: RA-65110

Introduction

On November 16, 2017, Aurora Cannabis Enterprises Inc., a licensed producer of cannabis for medical purposes located in Alberta, began a voluntary recall of one lot of Sundance borealis blend (sativa) dried marijuana under a Type II recall. The affected lot number can be found below.

Reason

On November 16, 2017, Aurora Cannabis Enterprises Inc. initiated a voluntary Type II recall for one lot of Sundance borealis blend (sativa), sold in 5 g bottles, due to an error in packaging of the product. The delta-9-tetrahydrocannabinol (THC) content identified on the label was higher and the cannabidiol (CBD) content identified on the label was lower than the concentration present in the product.

For lot 17-118-2042, the products packaged contained a THC value of 16.2% instead of 8.17% THC, and a CBD value of 0.05% instead of 5.91% CBD.

A Type II recall refers to a situation in which the use of, or exposure to a product may cause temporary adverse health consequences, or where the probability of serious adverse health consequences is remote.

To date, Health Canada has not received any adverse reaction reports for this product sold by Aurora Cannabis Enterprises Inc. However, Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Aurora Cannabis Enterprises Inc. at the following number 1-604-331-3434.

Affected products

Sundance borealis blend (sativa)

DIN, NPN, DIN-HIM Not Applicable Dosage form Not Applicable Not Applicable Strength 8.17% THC, 5.91% CBD Lot or serial number The following lot is classified under the Type II recall initiated on November 16, 2017. 17-118-2042 Companies Recalling Firm Aurora Cannabis Enterprises Inc.

Alberta

CANADA

Tel: 1-604-331-3434 Marketing Authorization Holder Not Applicable

Media enquiries

Health Canada

(613) 957-2983