Nitrosamine impurities in medications: Test results 

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Test results for sartans or angiotensin II receptor blockers (ARBs)

Health Canada has tested samples of ARBs on the Canadian market for NDMA and NDEA. The results, found in the table below, indicate:

We will continue to assess new developments to determine whether more testing is necessary.

Market Authorization Holder (Company) Name Product Name and DIN Strength
(mg)
Lot Number Expiry Date NDMA Result
ng/tablet
NDEA Result
ng/tablet
Recalled in Canada Date Added
Accel Pharma Inc. ACCEL-CANDESARTAN
DIN 02463784
32 1805003937 2020-02-29 Not Detected Not Detected No December 20, 2018
Actavis Pharma Company ACT VALSARTAN
DIN 02337517
320 K44166 2018-07-31 15242.72Table 1 Footnote 1 12.78 Yes December 20, 2018
Actavis Pharma Company ACT VALSARTAN
DIN 02337517
320 K45371 2018-10-31 10770.86Table 1 Footnote 1 186.67Table 1 Footnote 1 Yes December 20, 2018
Actavis Pharma Company ACT- OLMESARTAN
DIN 02442205
40 F83746 2020-03-31 Not Detected Not Detected No December 20, 2018
Angita Pharma Inc. AG-IRBESARTAN
DIN 02474417
300 IE317017AR 2019-10-31 Not Detected Not Detected No December 20, 2018
Apotex Inc. APO-OLMESARTAN/HCTZ
DIN 02453614
40/12.5 NF7704 2019-02-28 Not Detected Not Detected No December 20, 2018
Apotex Inc. APO-OLMESARTAN/HCTZ
DIN 02453614
40/12.5 NN7635 2019-12-31 Not Detected Not Detected No December 20, 2018
Apotex Inc. APO-LOSARTAN/HCTZ
DIN 02371235
50/12.5 NL1445 2019-08-31 Not Detected Not Detected No December 20, 2018
Apotex Inc. APO-LOSARTAN
DIN 02353512
100 NL1461 2019-08-31 Not Detected Not Detected No December 20, 2018
AstraZeneca Inc. ATACAND – CANDESARTAN
DIN 02311658
32 KL0275 2021-04-30 Not Detected Not Detected No December 20, 2018
Auro Pharma Inc. AURO-CANDESARTAN HCT
DIN 02421046
32/12.5 WKSA18004-A 2020-07-29 Not Detected Not Detected No December 20, 2018
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406098
75 IA7517001-A 2020-06-30 Not Detected 4.7 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406098
75 IA7517002-A 2020-11-05 Not Detected 4.44 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406098
75 IA7517003-A 2020-11-05 Not Detected 4.61 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406101
150 IA1517002-A 2020-10-31 Not Detected 9.77 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406101
150 IA1517001-A 2020-06-30 Not Detected 13.63Table 1 Footnote 2 NoTable 1 Footnote 2 April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406101
150 IA1517003-A 2020-10-31 Not Detected 8.97 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406128
300 IA3017001-A 2020-06-30 Not Detected 27.81Table 1 Footnote 2 NoTable 1 Footnote 2 April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406128
300 IA3017003-A 2020-10-31 Not Detected 17.47 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN
DIN 02406128
300 IA3017002-A 2020-10-31 Not Detected 19.6 No April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN HCT
DIN 02447894
300/25 IN3018001-A 2020-04-06 Not Detected 26.78Table 1 Footnote 2 NoTable 1 Footnote 2 April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN HCT
DIN 02447886
300/12.5 IR3018001-A 2020-04-06 Not Detected 30.29 This lot was never distributed April 29, 2019
Auro Pharma Inc. AURO-IRBESARTAN HCT
DIN 02447878
150/12.5 IN1518001-A 2020-04-06 Not Detected 15.82Table 1 Footnote 1 Yes April 29, 2019
Auro Pharma Inc. AURO-OLMESARTAN
DIN 02443872
40 WOSB18004-A 2020-01-12 Not Detected Not Detected No December 20, 2018
Auro Pharma Inc. AURO-LOSARTAN
DIN 02403358
100 WB1018003-A 2021-03-15 Not Detected Not Detected No December 20, 2018
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414201
40 VWSA17003-A 2019-10-31 Not Detected 1.41 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414201
40 VWSA18007-A 2020-08-24 Not Detected 1.07 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414201
40 VWSA18003-A 2020-08-23 Not Detected 1.04 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414228
80 VWSB17010-A 2019-07-31 Not Detected Not Detected No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414228
80 VWSB17011-A 2019-07-31 Not Detected Not Detected No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414236
160 VWSC17001-A 2018-12-31 Not Detected < 3.20 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414236
160 VWSC17005-A 2019-05-31 Not Detected < 3.20 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414236
160 VWSC18002-A 2020-01-19 Not Detected 4.58 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414236
160 VWSC18001-A 2020-01-19 < 6.40 4.39 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414236
160 VWSC18016-A 2020-08-24 Not Detected 4.7 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414244
320 VWSD17001-B 2019-05-31 Not Detected Not Detected No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414244
320 VWSD18005-A 2020-08-25 Not Detected 12.14 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414244
320 VWSD18001-A 2020-04-15 Not Detected 8.56 No January 16, 2019
Auro Pharma Inc. AURO-VALSARTAN
DIN 02414244
320 VWSD18001-A 2020-04-15 Not Detected 8.61 No December 20, 2018
Auro Pharma Inc. AURO-VALSARTAN HCT
DIN 02408112
80/12.5 HHSA18001-A 2021-08-02 Not Detected 1.88 No January 16, 2019
Jamp Pharma Corp JAMP-OLMESARTAN
DIN 02461668
40 MC218002A 2020-04-30 Not Detected Not Detected No December 20, 2018
Jamp Pharma Corp JAMP-LOSARTAN-HCTZ
DIN 02408252
100/25 LY218001A 2019-06-30 Not Detected Not Detected No December 20, 2018
Jamp Pharma Corp JAMP-IRBESARTAN
DIN 02418215
300 IE318005A 2020-03-31 Not Detected Not Detected No December 20, 2018
Merck Canada Inc. OLMETEC – OLMESARTAN
DIN 02318679
40 N021852 2020-04-30 Not Detected Not Detected No December 20, 2018
Mint Pharmaceuticals Inc. MINT-LOSARTAN/HCTZ DS
DIN 02389673
100/25 1805009844 2021-07-31 Not Detected Not Detected No December 20, 2018
Mylan Pharmaceuticals ULC MYLAN-VALSARTAN
DIN 02383527
40 3048813 2017-11-30 < 1.60 8.32 Yes January 16, 2019
Mylan Pharmaceuticals ULC MYLAN-VALSARTAN
DIN 02383535
80 3056368 2019-06-30 < 3.20 22.43 Yes January 16, 2019
Mylan Pharmaceuticals ULC MYLAN-VALSARTAN
DIN 02383543
160 3056371 2019-06-30 Not Detected 62.76 Yes January 16, 2019
Mylan Pharmaceuticals ULC MYLAN-VALSARTAN
DIN 02383551
320 3048815 2017-11-30 Not Detected 132.77 Yes January 16, 2019
Novartis Pharmaceuticals Canada Inc. DIOVAN
DIN 02289504
320 BEK32 2021-07-31 Not Detected Not Detected No December 20, 2018
Pharmascience Inc. PMS-CANDESARTAN HCTZ
DIN 02391295
16 615170 2020-04-30 Not Detected Not Detected No December 20, 2018
Pharmascience Inc. PMS-LOSARTAN
DIN 02309777
100 613936 2021-03-31 Not Detected 10.41 No December 20, 2018
Pharmascience Inc. PMS-LOSARTAN-HCTZ
DIN 02392232
100/12.5 0803847 2020-06-30 Not Detected Not Detected No December 20, 2018
Pharmascience Inc. PMS-IRBESARTAN
DIN 02317087
300 615908 2021-03-31 Not Detected Not Detected No December 20, 2018
Pharmascience Inc. PMS-IRBESARTAN-HCTZ
DIN 02328526
300/12.5 606524 2018-11-30 Not Detected Not Detected No December 20, 2018
Pharmascience Inc. PMS-IRBESARTAN-HCTZ
DIN 02328526
300/12.5 611016 2019-11-30 Not Detected Not Detected No December 20, 2018
Ranbaxy Pharmaceuticals Canada Inc. RAN-VALSARTAN
DIN 02363119
160 2884804 2019-05-31 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ CANDESARTAN
DIN 02417340
32 JC3223 2020-06-30 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ CANDESARTAN PLUS
DIN 02420732
32 HY8217 2020-04-30 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ OLMESARTAN
DIN 02443422
40 HX2039 2020-02-28 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ LOSARTAN
DIN 02313359
100 JD6746 2020-04-30 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ VALSARTAN
DIN 02356775
320 HW4965 2020-12-31 2703.76Table 1 Footnote 1 Not Detected Yes December 20, 2018
Sandoz Canada Inc. SANDOZ IRBESARTAN
DIN 02328496
300 HX4282 2020-01-31 Not Detected Not Detected No December 20, 2018
Sandoz Canada Inc. SANDOZ IRBESARTAN
DIN 02328496
300 JD1818 2020-05-31 Not Detected Not Detected No December 20, 2018
Sanis Health Inc. IRBESARTAN
DIN 02372398
300 35213058A 2019-12-31 Not Detected Not Detected No December 20, 2018
Sanofi-Aventis Canada Inc. AVAPRO – IRBESARTAN
DIN 02237925
300 KC001 2020-01-31 Not Detected Not Detected No December 20, 2018
Septa Pharmaceuticals Inc. SEPTA-LOSARTAN
DIN 02424983
100 LR318004A 2020-03-31 Not Detected Not Detected No December 20, 2018
Sivem Pharmaceuticals Inc. LOSARTAN HCT
DIN 02388987
100/25 QX1018005-B 2021-06-08 Not Detected Not Detected No December 20, 2018
Sivem Pharmaceuticals Inc. IRBESARTAN
DIN 02385309
300 HX7687 2019-12-31 Not Detected Not Detected No December 20, 2018
Sivem Pharmaceuticals Inc. IRBESARTAN HCT
DIN 02385325
300/12.5 HY7380 2020-11-30 Not Detected Not Detected No December 20, 2018
Teva Canada Limited TEVA-CANDESARTAN
DIN 02366339
32 2537058 2020-05-31 Not Detected Not Detected No December 20, 2018
Teva Canada Limited TEVA-LOSARTAN
DIN 02357976
100 2070318 2021-03-31 Not Detected Not Detected No December 20, 2018
Teva Canada Limited TEVA-LOSARTAN/HCTZ
DIN 02358263
50/12.5 35349397A 2020-09-30 Not Detected 10.3 No December 20, 2018
Teva Canada Limited TEVA-IRBESARTAN
DIN 02316412
300 35213086A 2019-12-31 Not Detected Not Detected No December 20, 2018
Teva Canada Limited TEVA-VALSARTAN
DIN 02356686
320 35211729R 2019-03-31 Not Detected Not Detected No December 20, 2018
Teva Canada Limited TEVA-VALSARTAN/HCTZ
DIN 02357038
320/12.5 35212732 2019-10-31 14538.35Table 1 Footnote 1 Not Detected This lot was never distributed December 20, 2018
Teva Canada Limited TEVA-VALSARTAN/HCTZ
DIN 02357038
320/12.5 35211546R 2019-01-31 258.19Table 1 Footnote 1 1770.87 Yes December 20, 2018
Teva Canada Limited TEVA-VALSARTAN/HCTZ
DIN 02357046
320/25 35212731R 2019-11-30 13367.64Table 1 Footnote 1 Not Detected Yes December 20, 2018
Table 1 Footnote 1

Indicates interim acceptable limits were exceeded based on NDMA limit of 96ng/day and NDEA limit of 26.5 ng/day. These values are based on a drug's maximum daily dose as reflected on the drug label.

Table 1 Return to footnote 1 referrer

Table 1 Footnote 2

The levels of nitrosamine impurities detected in this lot were very close to the acceptable limit. We determined that products from this lot don't represent a risk to Canadians and are safe to use.

Table 1 Return to footnote 2 referrer

Test results for ranitidines

Health Canada has tested samples of ranitidine products on the Canadian market for NDMA. We established an interim acceptable concentration limit of 0.32 ppm for NDMA based on a maximum recommended daily dose of 300 mg.

The results, found in the table below, indicate:

We will continue to assess new developments to determine whether more testing is necessary.

Market Authorization Holder (Company) Name Product Name and  DIN Strength (mg) Lot Number Expiry Date NDMA (ppm)Table 2 Footnote 1 Product Recalled
Laboratoire Riva Inc OPTION+ Acid Reducer (75 mg) DIN 02452464 75 612043-B 2020-05-30 0.1099 Yes
Pharmascience Inc LIFE BRAND Acid Reducer (150 mg) DIN 02400103 150 617496 2020-10-31 0.0816 Yes
Pharmascience Inc REXALL
Acid Reducer 02247551
75 611186D 2020-04-30 0.4779Table 2 Footnote 2 Yes
Pharmascience Inc Equate  Acid Reducer 02293471 150 618318 2020-10-31 0.0707 Yes
Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc ZANTAC 02230287 75 AK4388 2021-11-30 0.2452 Yes
Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc  ZANTAC 02277301 150 AK6951 2021-01-31 0.0904 Yes
Vita Health Products Inc Equate Acid Reducer 02298740 75 8E228B4RKB 2020-06-30 0.1246 Yes
Vita Health Products Inc Equate Acid Reducer 02298902 150 6152524N3J 2020-12-31 0.0526 Yes
Table 2 Footnote 1

Relative to declared amount of ranitidine

Table 2 Return to footnote 1 referrer

Table 2 Footnote 2

NDMA limit exceeded based on ranitidine's maximum recommended daily dose of 300 mg

Table 2 Return to footnote 2 referrer

Test results for Metformin

Health Canada has tested samples of metformin products on the Canadian market for NDMA. We established an interim acceptable concentration limit of 0.0376 ppm for NDMA for drug products with a maximum daily dose of 2.55 g/day, and 0.048 ppm for drug products with a maximum daily dose of 2 g/day.

The results, found in the table below, indicate:

We will continue to assess new developments to determine whether more testing is necessary.

Market Authorization Holder (Company) Name Product Name and  DIN Strength (mg) Lot Number Expiry Date NDMA (ppm)Table 3 Footnote 1 Product Recalled
Apotex Inc Apo-Metformin ER 02305062 500 PK3968 2020-09-30 0.044 ppm Yes
Apotex Inc Apo-Metformin ER 02460653 1000 PY5749 2021-03-31 NDTable 3 Footnote 2 No
Astrazeneca Canada Inc Xigduo 02449943 5/1000 X1032A 2022-07-31 ND No
Astrazeneca Canada Inc Komboglyze 02389185 2.5/1000 RB696 2022-04-30 ND No
Auro Pharma Inc Auro-Metformin 02438283 850 MR19008-85A 2022-04-15 ND No
Auro Pharma Inc Auro-Metformin 02438275 500 MR19054-50A 2022-04-28 ND No
Boehringer Ingelheim (Canada) Ltd Ltee Jentadueto 02403250 2.5/500 960201 2021-11-05 ND No
Boehringer Ingelheim (Canada) Ltd Ltee Jentadueto 02403277 2.5/1000 960205 2022-05-19 ND No
Boehringer Ingelheim (Canada) Ltd Ltee Jentadueto 02403269 2.5/850 958144 2022-03-26 ND No
Boehringer Ingelheim (Canada) Ltd Ltee Synjardy 02456591 5/1000 960496 2022-04-13 ND No
Dominion Pharmacal Dom-Metformin [Metformin 850] 02242726 850 624624 2021-09-30 ND No
Jamp Pharma Corporation Jamp-Metformin 02380218 850 X20386 2020-07-31 ND Yes
Janssen Inc Invokamet 02455455 150/1000 JIL0T01 2022-04-30 ND No
Laboratoire Riva Inc Riva-Metformin 02242783 850 C8385 2020-12-31 ND No
Merck Canada Inc Janumet Xr 02416786 50/500 R017925 2020-04-22 Detected; < LOQTable 3 Footnote 3 No
Merck Canada Inc Janumet 02333872 50/1000 R017774 2020-04-20 ND No
Merck Canada Inc Janumet 02333864 50/850 R031038 2020-08-12 ND No
Merck Canada Inc Janumet 02333856 50/500 N020597 2020-04-30 ND No
Merck Canada Inc Janumet Xr 02416794 50/1000 R015954 2020-04-21 Detected; < LOQ No
Merck Canada Inc Janumet Xr 02416808 100/1000 R019378 2020-04-28 Detected; < LOQ No
Mint Pharmaceuticals Inc Mint-Metformin 02388774 850 XB10217 2020-05-31 Detected; < LOQ No
Mylan Pharmaceuticals Ulc Mylan-Metformin [Metformin 850] 02229656 850 4680005A 2020-08-31 ND No
Pharmascience Inc Pms-Metformin [Metformin 850] 02242589 850 624407 2021-08-31 ND No
Pharmascience Inc Pms-Metformin -Tab 500mg [Metformin 500] 02223562 500 624584 2021-08-31 ND No
Pro Doc Limitee Pro-Metformin 02314894 850 624623 2021-09-30 ND No
Ranbaxy Pharmaceuticals Canada Inc. Ran-Metformin 02269058 850 AJZ8003A 2020-04-30 Detected; < LOQ No
Sandoz Canada Incorporated Sandoz Metformin Fc 02246820 500 HZ0133 2020-11-30 ND No
Sandoz Canada Incorporated Sandoz Metformin Fc 02246820 500 HT4634 2020-07-31 ND No
Sandoz Canada Incorporated Sandoz Metformin Fc 02246820 500 JD7946 2021-06-30 ND No
Sandoz Canada Incorporated Sandoz Metformin Fc 02246820 500 HL3031 2020-08-31 ND No
Sandoz Canada Incorporated Sandoz Metformin Fc 02246821 850 JR3918 2022-01-31 ND No
Sanis Health Inc Metformin 02353385 850 JJ1245 2021-05-31 ND No
Sanis Health Inc Metformin 02353385 850 JD0660 2021-05-31 ND No
Sanis Health Inc Metformin 02353377 500 JN3158 2021-10-31 ND No
Sanofi-Aventis Canada Inc Glucophage 02162849 850 8123285 2022-08-31 ND No
Sivem Pharmaceuticals Ulc Metformin Fc 02385341 500 JW5467 2022-04-30 ND No
Sivem Pharmaceuticals Ulc Metformin Fc 02385368 850 JR3921 2022-01-31 ND No
Sivem Pharmaceuticals Ulc Metformin Fc 02385368 850 JW8773 2022-05-31 ND No
Takeda Canada Inc Kazano 02417235 12.5/1000 11616020 2021-05-31 ND No
Teva Canada Limited Ratio-Metformin 02242931 850 35212386A 2020-03-31 ND No
Teva Canada Limited Act Metformin 02257726 500 4770082F 2021-05-31 ND No
Teva Canada Limited Act Metformin 02257734 850 4780009F 2020-10-31 ND No
Valeant Canada Lp/Valeant Canada S.E.C. Glumetza 02300451 1000 19L031P 2022-10-31 0.032 ppm No
Table 3 Footnote 1

Relative to declared amount of metformin

Table 3 Return to footnote 1 referrer

Table 3 Footnote 2

Under the limit of detection

Table 3 Return to footnote 2 referrer

Table 3 Footnote 3

Under the limit of quantification

Table 3 Return to footnote 3 referrer

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