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/R E P E A T -- Information Update - Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution/

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/R E P E A T -- Information Update - Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution/

Canada NewsWire

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:

  • do not contain valsartan manufactured by Zhejiang Huahai Pharmaceuticals, and
  • were manufactured using different processes from the ones that have been identified as having introduced the impurity.

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:

  • Continue taking their valsartan medication unless they have been advised to stop by their health care provider.
  • Contact their health care provider as soon as possible to discuss treatment options if they have been using an affected product. Pharmacists may be able to provide a product not affected by the recall, or doctors may prescribe a different medication for their patients' conditions.
  • Ask their pharmacist if they are unsure whether they are using a recalled product.

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

APO-VALSARTAN/HCTZ

02382555

160/12.5 mg

APO-VALSARTAN/HCTZ

02382563

160/25 mg

AURO-VALSARTAN

02414201

40 mg

AURO-VALSARTAN

02414228

80 mg

AURO-VALSARTAN

02414236

160 mg

AURO-VALSARTAN

02414244

320 mg

AURO-VALSARTAN HCT

02408112

80/12.5 mg

AURO-VALSARTAN HCT

02408120

160/12.5 mg

AURO-VALSARTAN HCT

02408139

160/25 mg

AURO-VALSARTAN HCT

02408147

320/12.5 mg

AURO-VALSARTAN HCT

02408155

320/25 mg

MYLAN-VALSARTAN

02383527

40 mg

MYLAN-VALSARTAN

02383535

80 mg

MYLAN-VALSARTAN

02383551

320 mg

PMS-VALSARTAN

02312999

40 mg

PMS-VALSARTAN

02313006

80 mg

PMS-VALSARTAN

02313014

160 mg

PMS-VALSARTAN

02344564

320 mg

RAN-VALSARTAN

02363062

40 mg

RAN-VALSARTAN

02363100

80 mg

RAN-VALSARTAN

02363119

160 mg

DIOVAN

02270528

40 mg

DIOVAN

02289504

320 mg

DIOVAN VALSARTAN

02236809

160 mg

DIOVAN VALSARTAN

02244782

160 mg

DIOVAN VALSARTAN

02236808

80 mg

DIOVAN VALSARTAN

02244781

80 mg

DIOVAN VALSARTAN HCT

02241900

80/12.5 mg

DIOVAN VALSARTAN HCT

02241901

160/12.5 mg

DIOVAN VALSARTAN HCT

02246955

160/25 mg

DIOVAN VALSARTAN HCT

02308908

320 mg

SANDOZ VALSARTAN HCT

02356694

80/12.5 mg

SANDOZ VALSARTAN HCT

02356708

160/12.5 mg

SANDOZ VALSARTAN HCT

02356716

160/25 mg

SANDOZ VALSARTAN HCT

02356724

320/12.5 mg

SANDOZ VALSARTAN HCT

02356732

320/25 mg

SANIS VALSARTAN HCT

02367009

80/12.5 mg

SANIS VALSARTAN HCT

02367017

160/12.5 mg

SANIS VALSARTAN HCT

02367025

160/25 mg

SANIS VALSARTAN HCT

02367033

320/12.5 mg

SANIS VALSARTAN HCT

02367041

320/25 mg

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384736

80/12.5 mg

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384744

160/12.5 mg

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384752

160/25 mg

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384760

320/12.5 mg

SIVEM PHARMACEUTICALS ULC VALSARTAN HCT

02384779

320/25 mg

 

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SOURCE Health Canada

View original content: http://www.newswire.ca/en/releases/archive/August2018/20/c4292.html

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