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DILART® and DILART®HCT (Valsartan) Tablets

Official notice

27 Nov 2018

Last checked

27 Nov 2018

Risk not stated by sourceACCC

An official ACCC notice concerns DILART® and DILART®HCT (Valsartan) Tablets. NDEA has been classified as a probable human carcinogen. Published 2018-11-27.

What to do now

Patients are asked to return any DILART® or DILART® HCT to the supplying pharmacy for a refund and to discuss replacement options. Patients who are on DILART® or DILART® HCT should NOT stop taking their medication prior to consulting a health care professional, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Pharmacists have been advised that patients should be offered an alternative brand or referred to their health care professional if an alternative treatment is required. Patients have been advised NOT to cease their medication without seeking advice from their health care professional. For further information please contact customer service on 1800 274 276.

Recall number

fd13834e-c743-42dc-8e62-bc140d1c23fe

Official notice

2018-11-27

The hazard

NDEA has been classified as a probable human carcinogen.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

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Affected products

Product 1

Valsartan is used for the treatment of hypertension and heart failure in patients. DILART® valsartan 40mg film-coated tablets (AUST R 167425) DILART® valsartan 80mg film-coated tablets (AUST R 167427) DILART® valsartan 160mg film-coated tablets (AUST R 167426) DILART® valsartan 320mg film-coated tablets (AUST R 167421) DILART® HCT 80/12.5mg valsartan 80mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187397) DILART® HCT 160/12.5mg valsartan 160mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187403) DILART® HCT 160/25mg valsartan 160mg/hydrochlorothiazide 25mg film-coated tablets (AUST R 187400) DILART® HCT 320/12.5mg valsartan 320mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187402) DILART® HCT 320/25mg valsartan 320mg/hydrochlorothiazide 25mg film-coated tablets (AUST R 187399) The following batches of Valsartan film coated tablets (DILART®): 40mg - 8058886 (expiry Mar-20); 8063916 (expiry Apr-20); 8065072 (expiry Jun-20); 8070855 (expiry Oct-20) 80mg - 8045929 (expiry Jan-19); 8063786 (expiry Apr-20); 8063762 (expiry Apr-20); 8061781 (expiry Feb-20); 8061781 (expiry May-20) 160mg - 8045896 (expiry Mar-19); 8055982 (expiry Jan-20); 8064559 (expiry Jan-20); 8062862 (expiry Mar-20) 320mg - 8045924 (expiry Mar-19); 8048002 (expiry Mar-19); 8059368 (expiry Mar-20); 8059896 (expiry Mar-20); 8063761 (expiry Mar-20); 8070229 (expiry Mar-20); 8073700 (expiry Apr-20) The following batches of Valsartan/ Hydrochlorothiazide film coated tablets (DILART® HCT): 80/12.5 mg - 8038886 (expiry Aug-19); 8076887 (expiry Mar-21) 160/12.5 mg - 8044826 (expiry Aug-19); 8076373 (expiry Mar-21) 160/25 mg - 8047518 (expiry Aug-19); 8075463 (expiry Mar-21) 320/12.5 mg - 8044825 (expiry Aug-19); 8075198 (expiry Mar-21) 320/25 mg - 8042677 (expiry Aug-19); 8075228 (expiry Mar-21)

Risk / hazard

NDEA has been classified as a probable human carcinogen.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

unspecified

Recall details

Recall number

fd13834e-c743-42dc-8e62-bc140d1c23fe

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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