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

Starting date:
August 18, 2018
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-67552

Update – August 31, 2018

The list of valsartan products that are NOT recalled has been updated to: provide corrected information for Diovan products; add an additional Mylan-Valsartan product; and to add Entresto products. No additional products have been recalled.

Update – August 21, 2018

This advisory has been updated to clarify the list of products that are NOT being recalled by adding a new column to the table (Lot #), and adding Teva Canada and Pro Doc Ltée products that are NOT being recalled.

Original Advisory – August 18, 2018

August 18, 2018

OTTAWA – 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.

Reason

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
MYLAN-VALSARTAN 02383543 160 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/12.5 mg All lots
DIOVAN HCT 02308916 320 mg/25mg 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
ENTRESTO 02446928 26 mg All lots
ENTRESTO 02446936 51 mg All lots
ENTRESTO 02446944 103 mg All lots

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