DILART® and DILART®HCT (Valsartan) Tablets
Published 27 November 2018
Product
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)
Why it was recalled
An impurity, N-nitrosodiethylamine (NDEA) has been found in batches of Valsartan.
Hazard
NDEA has been classified as a probable human carcinogen.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.