David Baxter PhD
Late Founder
Health Canada expands recall of some heart, high blood pressure drugs
CBC News
August 20, 2018
Affected medications contain valsartan manufactured at Zhejiang Huahai Pharmaceuticals in China
Patients with high blood pressure who take medications containing valsartan now will find 36 medications on Health Canada's recall list, made by companies including Teva Canada, Sandoz, Sanis, Pro Doc Ltée and Sivem Pharmaceuticals. Health Canada has added eight more products to its recall of certain medications containing valsartan, a drug used to treat high blood pressure and heart failure.
The affected valsartan was manufactured by Zhejiang Huahai Pharmaceuticals in China and may contain an impurity called NDMA (N-nitrosodimethylamine). NDMA is classified as a "probable human carcinogen," meaning scientists believe it could increase the risk of cancer if used above acceptable levels over a long period of time, according to Health Canada.
There are now a total of 36 valsartan medications on Health Canada's recall list, made by companies including Teva Canada, Sandoz, Sanis, Pro Doc Ltée and Sivem Pharmaceuticals. The initial recall was issued in July.
However, several medications containing valsartan — including some made by Sandoz, Sanis and Sivem — are not included in the recall, as the ingredient was not produced at the Zhejiang Huahai facility.
Health Canada said the recall is a precautionary measure, and that patients taking the affected medications should contact their health-care provider to discuss options, which could include substituting a different valsartan product not affected by the recall, or doctors prescribing a different type of medication.
'Don't stop taking medication'
A spokesperson for the Canadian Pharmacists Association said that while patients may be worried about the recall, they shouldn't stop taking their medication.
"There is concern especially with blood pressure medication," said Phil Emberley, who is also a practising pharmacist. "Don't stop taking your medication without consulting first, because your blood pressure could go up and that could cause a whole host of problems ... blood pressure can lead to a stroke or heart attack."
Emberley said it's important patients check with their health-care provider to determine if the medication they're taking has actually been recalled.
"I think it's important that people are aware about this," said Emberley. "If the medication happens to be recalled, there are other options. There are similar medications in the same class that are going to do the same thing."
Health Canada said it is assessing "how much NDMA patients may have been exposed to and for how long," noting that the agency believes the impurity began occurring when Zhejiang Huahai Pharmaceuticals changed its manufacturing processes in 2012.
A complete list of recalled products is provided below.
List of recalled products (products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals):
A complete list of products that are NOT recalled is provided below.
CBC News
August 20, 2018
Affected medications contain valsartan manufactured at Zhejiang Huahai Pharmaceuticals in China
Patients with high blood pressure who take medications containing valsartan now will find 36 medications on Health Canada's recall list, made by companies including Teva Canada, Sandoz, Sanis, Pro Doc Ltée and Sivem Pharmaceuticals. Health Canada has added eight more products to its recall of certain medications containing valsartan, a drug used to treat high blood pressure and heart failure.
The affected valsartan was manufactured by Zhejiang Huahai Pharmaceuticals in China and may contain an impurity called NDMA (N-nitrosodimethylamine). NDMA is classified as a "probable human carcinogen," meaning scientists believe it could increase the risk of cancer if used above acceptable levels over a long period of time, according to Health Canada.
There are now a total of 36 valsartan medications on Health Canada's recall list, made by companies including Teva Canada, Sandoz, Sanis, Pro Doc Ltée and Sivem Pharmaceuticals. The initial recall was issued in July.
However, several medications containing valsartan — including some made by Sandoz, Sanis and Sivem — are not included in the recall, as the ingredient was not produced at the Zhejiang Huahai facility.
Health Canada said the recall is a precautionary measure, and that patients taking the affected medications should contact their health-care provider to discuss options, which could include substituting a different valsartan product not affected by the recall, or doctors prescribing a different type of medication.
'Don't stop taking medication'
A spokesperson for the Canadian Pharmacists Association said that while patients may be worried about the recall, they shouldn't stop taking their medication.
"There is concern especially with blood pressure medication," said Phil Emberley, who is also a practising pharmacist. "Don't stop taking your medication without consulting first, because your blood pressure could go up and that could cause a whole host of problems ... blood pressure can lead to a stroke or heart attack."
Emberley said it's important patients check with their health-care provider to determine if the medication they're taking has actually been recalled.
"I think it's important that people are aware about this," said Emberley. "If the medication happens to be recalled, there are other options. There are similar medications in the same class that are going to do the same thing."
Health Canada said it is assessing "how much NDMA patients may have been exposed to and for how long," noting that the agency believes the impurity began occurring when Zhejiang Huahai Pharmaceuticals changed its manufacturing processes in 2012.
A complete list of recalled products is provided below.
| 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 |
A complete list of products that are NOT recalled is provided below.
| 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 |
