(Update - August 18, 2018) Drugs containing valsartan being recalled due to contamination with potential carcinogen

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Drugs containing valsartan being recalled due to contamination with potential carcinogen

 

Update - August 18, 2018

Health Canada - Teva Canada expands recall of valsartan drugs to include additinoal lots, as a precaution

Further to the initial recall of certain valsartan products because of the presence of NDMA in the active ingredient, Health Canada is now 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).   

Product Name/active pharmaceutical ingredient din strength lot #
TEVA-VALSARTAN/HCTZ TABLETS 02356996 80/12.5 mg 35211136A
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211335A
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211844R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210937R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210938R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210939R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210940R
TEVA-VALSARTAN/HCTZ TABLETS 02357038 320/12.5 mg 35211546R

July 10, 2018

Health Canada has issued a recall for several drugs containing valsartan due to contamination with potential carcinogen.

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke as well as patients who have had heart failure or a recent heart attack.

Patients are advised to keep taking their medicine until they talk with their pharmacist or primary care provider to determine if their medication is affected.

Pharmacists and primary care providers will work together with patients who are affected to help them safely transition to an alternative medication.

Pharmacists can provide recommendations for safe therapeutic alternatives and provide therapeutic substitutions as needed (following the requirements under Professional Practice Policy-58: Medication Management (Adapting a Prescription)).

For practice support related to the recall, questions can be directed to: 

[email protected]  

Quick Links

Health Canada Recall Advisory

From Health Canada – Several drugs containing valsartan being recalled due to contamination with a potential carcinogen (July 9, 2018)

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart attack.

The following products have been affected:

Product Name DIN Strength Lot#
TEVA-VALSARTAN/HCTZ TABLETS 02356996 80/12.5 mg 35211136A
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211335A
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211844R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210937R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210938R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210939R
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210940R
TEVA-VALSARTAN/HCTZ TABLETS 02357038 320/12.5 mg 35211546R
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47653
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80mg K47654
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K39691
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K44167
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47657
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47658
ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K44166
ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K45371
SANDOZ VALSARTAN 40 MG 02356740 40 mg All lots
SANDOZ VALSARTAN 80 MG 02356759 80 mg All lots
SANDOZ VALSARTAN 160 MG 02356767 160 mg All lots
SANDOZ VALSARTAN 320 MG 02356775 320 mg All lots
SANIS VALSARTAN 40 MG 02366940 40 mg All lots
SANIS VALSARTAN 80 MG 02366959 80 mg All lots
SANIS VALSARTAN 160 MG 02366967 160 mg All lots
SANIS VALSARTAN 320 MG 02366975 320 mg All lots
PRO DOC LIMITEE VALSARTAN 40 MG 02367726 40 mg All lots
PRO DOC LIMITEE VALSARTAN 80 MG 02367734 80 mg All lots
PRO DOC LIMITEE VALSARTAN 160 MG 02367742 160 mg All lots
PRO DOC LIMITEE VALSARTAN 320 MG 02367750 320 mg All lots
SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG 02384523 40 mg All lots
SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG 02384531 80 mg All lots
SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG 02384558 160 mg All lots
SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG 02384566 320 mg All lots

Advice for Patients

  • Keep taking your medicine if it contains valsartan, unless you have been told to stop by your doctor or pharmacist
  • If you are taking any medication containing valsartan, speak to your pharmacist who can tell you if your medicine is being recalled
  • If you have been using an affected product, contact your health care practitioner as soon as possible to discuss your treatment options
  • If you are in a clinical trial with a product containing valsartan and have any questions, speak to the doctor treating you in the trial
  • Report side effects (adverse events) to health products to Health Canada by calling toll-free 1-866-234-2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

 

PHARMACARE INFORMATION:VALSARTAN RECALL

From PharmaCare Recall Valsartan Notice (July 10)

The recall affects up to 90% of single-molecule valsartan products. Except for TEVA-Valsartan/HCTZ 320/25mg (DIN 02357046), most formulations of valsartan-hydrochlorothiazide are not affected by the recall. 

Pharmacy Recall Procedures 

Pharmacies should use their standard corporate recall processes to identify and inform patients who currently have a supply of any of the affected lot numbers or DINs. Patients should be requested to replace their existing supply as soon as possible. 

More details available in the PharmaCare Recall Valsartan Notice (July 10).

Reference Drug Program 

Valsartan is an RDP (Reference Drug Program) reference drug, subject to LCA (low-cost alternative) pricing. At this time, because there is a sufficient supply of valsartan that is not affected by the recall, PharmaCare coverage for the brand name product, Diovan®, remains at the LCA price. 
 
Due to the volume of products affected, the recall is likely to result in an actual shortage. In this event, reimbursement for Diovan may be adjusted. 
 

 

Therapeutic Substitutions 

As with any RDP drug, pharmacists may switch patients to another product within the RDP category if such a switch would be beneficial to the patient, allowable under the College of Pharmacists Professional Practice Policy 58, and result in a lower (or same) cost to PharmaCare. 

Due to the nature of the valsartan recall, pharmacists may encounter patients eager to switch their medication. Please refer to: 

Aug 20, 2018