Recall of Cannabis for Medical Purposes - Organigram Inc.

Starting date: January 9, 2017 Type of communication: Drug Recall Subcategory: Drugs Hazard classification: Type II and III Source of recall: Health Canada Issue: Undeclared Substance Audience: General Public Identification number: RA-61750

Introduction

On January 9, 2017, Organigram Inc., a licensed producer of cannabis for medical purposes located in New Brunswick, began a voluntary recall of sixty-nine lots of product under a Type II recall, in addition to 5 lots of product under a Type III recall that was initiated on December 28, 2016. The products that are being recalled include dried marijuana and cannabis oil that were produced between February 1, 2016 and December 16, 2016. The affected lot numbers are found below.

Reason

On December 28, 2016, Organigram Inc. initiated a voluntary Type III recall after 5 lots of product tested positive for the presence of low levels of myclobutanil and/or bifenazate which are not found in the thirteen pesticides that are authorized for use on cannabis plants under the Pest Control Products Act. These two ingredients are found in pest control products that are approved for use in food production.

On January 9, 2017, Organigram Inc. initiated a voluntary Type II recall, following subsequent testing which identified additional lots containing residual levels of myclobutanil and/or bifenazate that exceeded any of the levels permitted in food production for these two pesticides. As a precautionary measure, Organigram Inc. expanded the voluntary Type II recall to include all products produced between February 1 and December 16, 2016.

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. 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.

Health Canada has received one adverse reaction report related to Organigram Inc.'s products sold during the period covered by the recall. Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Organigram Inc. at the following number 1-855-961-9420.

Affected products

Dried marijuana 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 II recall initiated on January 9, 2017. 186

196

568

612

614

631

0484 4120 9186 4217

0632 9020 5186 1584

0698 3979 5670 4013

0835 2499 3080 3152

1039 6743 0096 3064

1128 2207 5306 8356

1214 4385 7876 4963

1248 8565 0909 0116

1392 2140 59402203

1530 5385 8865 0723

1692 8722 7100 7769

1798 3262 0332 9024

1869 8785 4606 7699

2030 8854 6974 3698

2425 5257 9734 5279

2707 7316 6422 8456

2724 3857 7503 4219

2832 0173 5225 2831

3017 4730 1276 8084

3353 1673 3760 8098

3457 1488 3880 0879

3659 5990 7510 5577

3676 2712 8761 2809

3732 6805 4306 4209

4257 5804 1380 5978

4546 3441 5773 5387

4617 9711 2847 2539

4709 0039 8177 6510

4865 2707 2710 2013

4979 9968 5040 4225

5044 0498 7172 7996

5167 2552 4451 3242

5556 5590 5362 5049

5560 8059 3978 5025

5692 9617 0958 9847

5908 6644 8564 0243

5916 2665 7125 6723

6093 0421 1532 2816

6338 1409 1316 9568

6642 5297 9577 0719

6677 6317 7798 5134

6699 6144 5961 2305

6952 1539 1506 3684

7347 1403 5310 8248

7889 4737 3645 1644

7942 5711 8236 3848

7960 7185 3171 4982

7998 0446 5884 4992

8343 9021 8073 9701

8522 6652 7965 8394

8573 8735 4099 6063

8702 3966 6164 2065

8721 7829 4773 5980

8757 8743 2054 3792

8923 5206 8182 7901

8988 3254 9463 8382

9018 0053 5952 4151

9073 9120 9510 9254

9430 1622 3667 6094

9464 9903 4263 4784

9572 8784 0739 8911

9653 4459 4335 1330

9670 7459 2887 2510 Companies Recalling Firm Organigram Inc.

New Brunswick

CANADA

Tel: 1-855-961-9420 Marketing Authorization Holder Not Applicable

Dried marijuana or cannabis oil

DIN, NPN, DIN-HIM Not Applicable Dosage form Not Applicable Not Applicable Strength Not Applicable Lot or serial number The following lots are classified under the Type III recall initiated on December 28, 2016. 3648 0303 4839 6093

7890 3697 2268 9876

569

611

661 Companies Recalling Firm Organigram Inc.

New Brunswick

CANADA

Tel: 1-855-961-9420 Marketing Authorization Holder Not Applicable

Media enquiries

Health Canada

(613) 957-2983