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

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

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	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

Related Links

• Health Canada advisory (2018-07-09): Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Également disponible en français

SOURCE Health Canada

Media Inquiries: Health Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709