Valsartan Drug Recall Expands [Canada]


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Canada/Ottawa: Valsartan Drug Recall [Canada]Health Canada expands its recall of various  Valsartan-based drugs due to the suspected presence of N-nitrosodimethylamine (“NDMA”), a potential human carcinogen, and consequential risk of Cancer, all serious health and safety hazards.

HCSC: http://ht.ly/L4HR30lsJFP

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67552a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Valsartan-based Drugs are subject to this recall:

  • Act-Valsartan 160 mg FC Tablets 100, sold with a DIN of 02337509, a dosage strength of 160 mg, a batch/lot designation of K39691 and added on July 9, 2018
  • Act-Valsartan 160 mg FC Tablets 100, sold with a DIN of 02337509, a dosage strength of 160 mg, a batch/lot designation of K44167 and added on July 9, 2018
  • Act-Valsartan 160 mg FC Tablets 100, sold with a DIN of 02337509, a dosage strength of 160 mg, a batch/lot designation of K47657 and added on July 9, 2018
  • Act-Valsartan 160 mg FC Tablets 100, sold with a DIN of 02337509, a dosage strength of 160 mg, a batch/lot designation of K47658 and added on July 9, 2018
  • Act-Valsartan 320 mg FC Tablets 100, sold with a DIN of 02337517, a dosage strength of 320 mg, a batch/lot designation of K44166 and added on July 9, 2018
  • Act-Valsartan 320 mg FC Tablets 100, sold with a DIN of 02337517, a dosage strength of 320 mg, a batch/lot designation of K45371 and added on July 9, 2018
  • Act-Valsartan 40 mg FC Tablets 100, sold with a DIN of 02337487, a dosage strength of 40 mg, a batch/lot designation of K47338 and added on July 9, 2018
  • Act-Valsartan 80 mg FC Tablets 100, sold with a DIN of 02337495, a dosage strength of 80 mg, a batch/lot designation of K45370 and added on July 9, 2018
  • Act-Valsartan 80 mg FC Tablets 100, sold with a DIN of 02337495, a dosage strength of 80 mg, a batch/lot designation of K47652 and added on July 9, 2018
  • Act-Valsartan 80 mg FC Tablets 100, sold with a DIN of 02337495, a dosage strength of 80 mg, a batch/lot designation of K47653 and added on July 9, 2018
  • Act-Valsartan 80 mg FC Tablets 100, sold with a DIN of 02337495, a dosage strength of 80 mg, a batch/lot designation of K47654 and added on July 9, 2018
  • Pro Doc Limitee Valsartan 160 mg, sold with a DIN of 02367742, a dosage strength of 160 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Pro Doc Limitee Valsartan 320 mg, sold with a DIN of 02367750, a dosage strength of 320 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Pro Doc Limitee Valsartan 40 mg, sold with a DIN of 02367726, a dosage strength of 40 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Pro Doc Limitee Valsartan 80 mg, sold with a DIN of 02367734, a dosage strength of 80 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sandoz Valsartan 160 mg, sold with a DIN of 02356767, a dosage strength of 160 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sandoz Valsartan 320 mg, sold with a DIN of 02356775, a dosage strength of 320 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sandoz Valsartan 40 mg, sold with a DIN of 02356740, a dosage strength of 40 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sandoz Valsartan 80 mg, sold with a DIN of 02356759, a dosage strength of 80 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sanis Valsartan 160 mg, sold with a DIN of 02366967, a dosage strength of 160 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sanis Valsartan 320 mg, sold with a DIN of 02366975, a dosage strength of 320 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sanis Valsartan 40 mg, sold with a DIN of 02366940, a dosage strength of 40 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sanis Valsartan 80 mg, sold with a DIN of 02366959, a dosage strength of 80 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sivem Pharmaceutical ULC Valsartan 160 mg, sold with a DIN of 02384558, a dosage strength of 160 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sivem Pharmaceutical ULC Valsartan 320 mg, sold with a DIN of 02384566, a dosage strength of 320 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sivem Pharmaceutical ULC Valsartan 40 mg, sold with a DIN of 02384523, a dosage strength of 40 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Sivem Pharmaceutical ULC Valsartan 80 mg, sold with a DIN of 02384531, a dosage strength of 80 mg, affected batch/lot designations: all lots and added on July 9, 2018
  • Teva-Valsartan/Hctz Tablets PP 30s, sold with a DIN of 02357046, a dosage strength of 320/25 mg, a batch/lot designation of 35212731R and added on July 9, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02356996 80/12.5 mg, a batch/lot designation of 35211136A and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357003, a dosage strength of 160/12.5 mg, a batch/lot designation of 35211335A and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357003, a dosage strength of 160/12.5 mg, a batch/lot designation of 35211844R and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357011, a dosage strength of 160/25 mg, a batch/lot designation of 35210937R and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357011, a dosage strength of 160/25 mg, a batch/lot designation of 35210938R and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357011, a dosage strength of 160/25 mg, a batch/lot designation of 35210939R and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357011, a dosage strength of 160/25 mg, a batch/lot designation of 35210940R and added on August 17, 2018
  • Teva-Valsartan/Hctz Tablets, sold with a DIN of 02357038, a dosage strength of 320/12.5 mg, a batch/lot designation of 35211546R and added on August 17, 2018

The following drugs were recalled under an earlier notification:

  • ACT-Valsartan 160mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337509, a dosage strength of 160 mg and a batch/lot designation of K39691
  • ACT-Valsartan 160mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337509, a dosage strength of 160 mg and a batch/lot designation of K44167
  • ACT-Valsartan 160mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337509, a dosage strength of 160 mg and a batch/lot designation of K47657
  • ACT-Valsartan 160mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337509, a dosage strength of 160 mg and a batch/lot designation of K47658
  • ACT-Valsartan 320mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337517, a dosage strength of 320 mg and a batch/lot designation of K44166
  • ACT-Valsartan 320mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337517, a dosage strength of 320 mg and a batch/lot designation of K45371
  • ACT-Valsartan 40mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337487, a dosage strength of 40 mg and a batch/lot designation of K47338
  • ACT-Valsartan 80mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337495, a dosage strength of 80 mg and a batch/lot designation of K45370
  • ACT-Valsartan 80mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337495, a dosage strength of 80 mg and a batch/lot designation of K47652
  • ACT-Valsartan 80mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337495, a dosage strength of 80 mg and a batch/lot designation of K47653
  • ACT-Valsartan 80mg FC Tablets 100, sold with a drug identification number (“DIN”) of 02337495, a dosage strength of 80mg and a batch/lot designation of K47654
  • Pro Doc Limitee Valsartan 160 mg, sold with a drug identification number (“DIN”) of 02367742 and a dosage strength of 160 mg. All batch/lots are affected by this recall
  • Pro Doc Limitee Valsartan 320 mg, sold with a drug identification number (“DIN”) of 02367750 and a dosage strength of 320 mg. All batch/lots are affected by this recall
  • Pro Doc Limitee Valsartan 40 mg, sold with a drug identification number (“DIN”) of 02367726 and a dosage strength of 40 mg. All batch/lots are affected by this recall
  • Pro Doc Limitee Valsartan 80 mg, sold with a drug identification number (“DIN”) of 02367734 and a dosage strength of 80 mg. All batch/lots are affected by this recall
  • Sandoz Valsartan 160 mg, sold with a drug identification number (“DIN”) of 02356767 and a dosage strength of 160 mg. All batch/lots are affected by this recall
  • Sandoz Valsartan 320 mg, sold with a drug identification number (“DIN”) of 02356775 and a dosage strength of 320 mg. All batch/lots are affected by this recall
  • Sandoz Valsartan 40 mg, sold with a drug identification number (“DIN”) of 02356740 and a dosage strength of 40 mg. All batch/lots are affected by this recall
  • Sandoz Valsartan 80 mg, sold with a drug identification number (“DIN”) of 02356759 and a dosage strength of 80 mg. All batch/lots are affected by this recall
  • Sanis Valsartan 160 mg, sold with a drug identification number (“DIN”) of 02366967 and a dosage strength of 160 mg. All batch/lots are affected by this recall
  • Sanis Valsartan 320 mg, sold with a drug identification number (“DIN”) of 02366975 and a dosage strength of 320 mg. All batch/lots are affected by this recall
  • Sanis Valsartan 40 mg, sold with a drug identification number (“DIN”) of 02366940 and a dosage strength of 40 mg. All batch/lots are affected by this recall
  • Sanis Valsartan 80 mg, sold with a drug identification number (“DIN”) of 02366959 and a dosage strength of 80 mg. All batch/lots are affected by this recall
  • Sivem Pharmaceutical ULC Valsartan 160 mg, sold with a drug identification number (“DIN”) of 02384558 and a dosage strength of 160 mg. All batch/lots are affected by this recall
  • Sivem Pharmaceutical ULC Valsartan 320 mg, sold with a drug identification number (“DIN”) of 02384566 and a dosage strength of 320 mg. All batch/lots are affected by this recall
  • Sivem Pharmaceutical ULC Valsartan 40 mg, sold with a drug identification number (“DIN”) of 02384523, and a dosage strength of 40 mg. All batch/lots are affected by this recall
  • Sivem Pharmaceutical ULC Valsartan 80 mg, sold with a drug identification number (“DIN”) of 02384531 and a dosage strength of 80 mg. All batch/lots are affected by this recall
  • Teva-Valsartan/Hctz Tablets PP 30s 02357046, a dosage strength of 320/25 mg and a batch/lot designation of 35212731R

According to Health Canada, several drugs containing the active ingredient Valsartan have been 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, meaning it could cause Cancer with long-term exposure. Five (5) companies have affected drug products.

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 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.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

Health Canada suggests the following:

  • 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 option

If you have any questions about this recall, please contact Health Canada at 1-613-957-2991
or toll-free at 1-866-225-0709 during normal business hours, Eastern Standard Time.

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More information about this recall:
HCSC ID number: RA-67552
Recalls Direct RIN: 10528-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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