Le Lézard
Classified in: Health
Subject: CFG

Information Update - Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution



OTTAWA, Aug. 18, 2018 /CNW/ - Health Canada is advising Canadians that, as a precautionary measure, Teva Canada is expanding its voluntary recall to include eight additional lots of valsartan products in Canada because they may contain an impurity, N-nitrosodimethylamine (NDMA).

Valsartan is used to treat high blood pressure and heart failure.

This latest action is further to an initial recall of certain valsartan products because of the presence of NDMA in the active ingredient (valsartan). All of the recalled products use a valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals in China.

Products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals

Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients. NDMA is classified as a probable human carcinogen based primarily on animal studies, which means that exposure above acceptable levels over the long term could increase the risk of cancer. The review, which will be completed in the coming weeks, will include an assessment of how much NDMA patients may have been exposed to and for how long. Although Health Canada believes that the NDMA was introduced as a result of a change in manufacturing processes at Zhejiang Huahai Pharmaceuticals in 2012, some Canadian companies may have been using the affected valsartan active ingredient for less time.

The additional Teva Canada products are being recalled after sample testing of the active ingredient by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA. Testing is ongoing. In the meantime, Health Canada has asked Teva Canada to recall these additional products as a precautionary measure, and to conduct a full investigation to determine the root cause of this most recent issue.

Health Canada is monitoring the recalls. The Department continues to work with the companies and its international regulatory partners to gather and assess information to determine whether additional actions are necessary. We will keep Canadians updated. This includes communicating the results of our health risk assessment once it is complete in the coming weeks.

A complete list of recalled products is provided below.

Products containing valsartan ingredient from other suppliers NOT impacted by the recall

Health Canada has contacted all companies selling valsartan medications in Canada and has confirmed that all of the products NOT being recalled:

Health Canada continues to work with companies selling valsartan medications to determine whether their processes are at risk of producing NDMA.

Health Canada is also working with stakeholders to monitor the Canadian supply of valsartan products and alternative medications.

A complete list of products that are NOT recalled is provided below.

What you should do

Patients taking affected valsartan medications should:

List of recalled products (products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals):

 

Product name/Active Pharmaceutical Ingredient

DIN

Strength

Lot #

Date added

TEVA-VALSARTAN/HCTZ TABLETS

02356996

80/12.5 mg

35211136A

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357003

160/12.5 mg

35211335A

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357003

160/12.5 mg

35211844R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357011

160/25 mg

35210937R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357011

160/25 mg

35210938R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357011

160/25 mg

35210939R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357011

160/25 mg

35210940R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS

02357038

320/12.5 mg

35211546R

August 17, 2018

TEVA-VALSARTAN/HCTZ TABLETS PP 30s

02357046

320/25 mg

35212731R

July 9, 2018

ACT-VALSARTAN 40MG FC TABLETS 100

02337487

40 mg

K47338

July 9, 2018

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80 mg

K45370

July 9, 2018

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80 mg

K47652

July 9, 2018

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80 mg

K47653

July 9, 2018

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80mg

K47654

July 9, 2018

ACT-VALSARTAN 160MG FC TABLETS 100

02337509

160 mg

K39691

July 9, 2018

ACT-VALSARTAN 160MG FC TABLETS 100

02337509

160 mg

K44167

July 9, 2018

ACT-VALSARTAN 160MG FC TABLETS 100

02337509

160 mg

K47657

July 9, 2018

ACT-VALSARTAN 160MG FC TABLETS 100

02337509

160 mg

K47658

July 9, 2018

ACT-VALSARTAN 320MG FC TABLETS 100

02337517

320 mg

K44166

July 9, 2018

ACT-VALSARTAN 320MG FC TABLETS 100

02337517

320 mg

K45371

July 9, 2018

SANDOZ VALSARTAN 40 MG

02356740

40 mg

All lots

July 9, 2018

SANDOZ VALSARTAN 80 MG

02356759

80 mg

All lots

July 9, 2018

SANDOZ VALSARTAN 160 MG

02356767

160 mg

All lots

July 9, 2018

SANDOZ VALSARTAN 320 MG

02356775

320 mg

All lots

July 9, 2018

SANIS VALSARTAN 40 MG

02366940

40 mg

All lots

July 9, 2018

SANIS VALSARTAN 80 MG

02366959

80 mg

All lots

July 9, 2018

SANIS VALSARTAN 160 MG

02366967

160 mg

All lots

July 9, 2018

SANIS VALSARTAN 320 MG

02366975

320 mg

All lots

July 9, 2018

PRO DOC LIMITEE VALSARTAN 40 MG

02367726

40 mg

All lots

July 9, 2018

PRO DOC LIMITEE VALSARTAN 80 MG

02367734

80 mg

All lots

July 9, 2018

PRO DOC LIMITEE VALSARTAN 160 MG

02367742

160 mg

All lots

July 9, 2018

PRO DOC LIMITEE VALSARTAN 320 MG

02367750

320 mg

All lots

July 9, 2018

SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG

02384523

40 mg

All lots

July 9, 2018

SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG

02384531

80 mg

All lots

July 9, 2018

SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG

02384558

160 mg

All lots

July 9, 2018

SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG

02384566

320 mg

All lots

July 9, 2018

 

List of products that are NOT recalled (products that do NOT contain the valsartan active ingredient from Zhejiang Huahai Pharmaceuticals):

 

Product name/Active Pharmaceutical Ingredient

DIN

Strength

Lot #

APO-VALSARTAN/HCTZ

02382555

160/12.5 mg

All lots

APO-VALSARTAN/HCTZ

02382563

160/25 mg

All lots

AURO-VALSARTAN

02414201

40 mg

All lots

AURO-VALSARTAN

02414228

80 mg

All lots

AURO-VALSARTAN

02414236

160 mg

All lots

AURO-VALSARTAN

02414244

320 mg

All lots

AURO-VALSARTAN HCT

02408112

80/12.5 mg

All lots

AURO-VALSARTAN HCT

02408120

160/12.5 mg

All lots

AURO-VALSARTAN HCT

02408139

160/25 mg

All lots

AURO-VALSARTAN HCT

02408147

320/12.5 mg

All lots

AURO-VALSARTAN HCT

02408155

320/25 mg

All lots

MYLAN-VALSARTAN

02383527

40 mg

All lots

MYLAN-VALSARTAN

02383535

80 mg

All lots

MYLAN-VALSARTAN

02383551

320 mg

All lots

PMS-VALSARTAN

02312999

40 mg

All lots

PMS-VALSARTAN

02313006

80 mg

All lots

PMS-VALSARTAN

02313014

160 mg

All lots

PMS-VALSARTAN

02344564

320 mg

All lots

RAN-VALSARTAN

02363062

40 mg

All lots

RAN-VALSARTAN

02363100

80 mg

All lots

RAN-VALSARTAN

02363119

160 mg

All lots

DIOVAN

02270528

40 mg

All lots

DIOVAN

02289504

320 mg

All lots

DIOVAN VALSARTAN

02236809

160 mg

All lots

DIOVAN VALSARTAN

02244782

160 mg

All lots

DIOVAN VALSARTAN

02236808

80 mg

All lots

DIOVAN VALSARTAN

02244781

80 mg

All lots

DIOVAN VALSARTAN HCT

02241900

80/12.5 mg

All lots

DIOVAN VALSARTAN HCT

02241901

160/12.5 mg

All lots

DIOVAN VALSARTAN HCT

02246955

160/25 mg

All lots

DIOVAN VALSARTAN HCT

02308908

320 mg

All lots

SANDOZ VALSARTAN HCT

02356694

80/12.5 mg

All lots

SANDOZ VALSARTAN HCT

02356708

160/12.5 mg

All lots

SANDOZ VALSARTAN HCT

02356716

160/25 mg

All lots

SANDOZ VALSARTAN HCT

02356724

320/12.5 mg

All lots

SANDOZ VALSARTAN HCT

02356732

320/25 mg

All lots

SANIS VALSARTAN HCT

02367009

80/12.5 mg

All lots

SANIS VALSARTAN HCT

02367017

160/12.5 mg

All lots

SANIS VALSARTAN HCT

02367025

160/25 mg

All lots

SANIS VALSARTAN HCT

02367033

320/12.5 mg

All lots

SANIS VALSARTAN HCT

02367041

320/25 mg

All lots

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384736

80/12.5 mg

All lots

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384744

160/12.5 mg

All lots

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384752

160/25 mg

All lots

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384760

320/12.5 mg

All lots

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384779

320/25 mg

All lots

TEVA-VALSARTAN

02356643

40 mg

All lots

TEVA-VALSARTAN

02356651

80 mg

All lots

TEVA-VALSARTAN

02356678

160 mg

All lots

TEVA-VALSARTAN

02356686

320 mg

All lots

TEVA-VALSARTAN/HCTZ

02356996

80/12.5 mg

All lots except for the recalled lot 35211136A

TEVA-VALSARTAN/HCTZ

02357003

160/12.5 mg

All lots except for the recalled lots  35211335A  and 35211844R-

TEVA-VALSARTAN/HCTZ

02357011

160/25 mg

All lots except for the recalled lots 35210937R  35210938R

35210939R  35210940R

TEVA-VALSARTAN/HCTZ

02357038

320/12.5 mg

All lots except for the recalled lot 35211546R

TEVA-VALSARTAN/HCTZ

02357046

320/25 mg

All lots except for the recalled lot 35212731R

PRO DOC VALSARTAN /HCTZ

02367769

80/12.5 mg

All lots

PRO DOC VALSARTAN /HCTZ

02367777

160/12.5 mg

All lots

PRO DOC VALSARTAN /HCTZ

02367785

160/25 mg

All lots

 

Related Links

Également disponible en français

 

SOURCE Health Canada


These press releases may also interest you

at 14:32
The old approach to cannabis did not work. It let criminals and organized crime profit, while failing to keep cannabis out of the hands of Canadian youth. In many cases, it has been easier for our kids to buy cannabis than cigarettes. To address...

at 14:22
Minister of Agriculture and Agri-Food Lawrence MacAulay and Parliamentary Secretary Jean-Claude Poissant, will speak to the government-led efforts to improve the mental health and physical well-being of farmers and those in the agriculture sector....

at 14:15
The "Investigation Report on China's Metoprolol Market, 2018-2022" report has been added to ResearchAndMarkets.com's offering. Estimated according to the population size and structure, there are about 330 million hypertensive patients in China, which...

at 14:10
IssueOne lot each of Option+ Family Sunscreen Lotion SPF 50+ and Personnelle Sport Sunscreen Lotion SPF 50+ have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination. The sunscreens were found to contain multiple...

at 14:09
AdventHealth University's (AHU) Master of Science in Physician Assistant Studies (PA) program received a 100% passing rate for its August 2018 cohort. This is a real milestone considering this is only the second cohort of AHU PA graduates to take the...

at 13:50
As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA's labeling tools to foster innovation toward healthier foods that...




News published on 21 august 2018 at 13:31 and distributed by: