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

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

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