Alphapharm Pty Ltd (trading as Mylan Australia), after consultation with the Therapeutic Goods Administration (TGA), is initiating a voluntary, nationwide, consumer-level recall of all batches of DILART® and DILART® HCT.
The recall is being undertaken as a precautionary measure due to the potential presence of trace amounts of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen. The estimated risk from use of these tablets is very low.
The recall applies to all batches of the following products distributed between August 2016 and November 2018:
· 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 80mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187402)
· DILART® HCT 320/12.5mg valsartan 80mg/hydrochlorothiazide 25mg film-coated tablets (AUST R 187399)
Valsartan is used for the treatment of hypertension, for the treatment of heart failure in patients receiving usual therapy who are intolerant to ACE inhibitors, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with hydrochlorothiazide is used to control high blood pressure.
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.
Alphapharm is notifying wholesalers, pharmacists and healthcare professionals by letter and is arranging for return of all recalled products.
Alphapharm sincerely regrets any inconvenience to customers.
