APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets
Published 7 January 2019
Product
These valsartan-containing products are used to treat high blood pressure (also known as hypertension) and other heart-related disorders. APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets APO-VALSARTAN valsartan 40 mg tablet blister pack All batches APO-VALSARTAN valsartan 80 mg tablet blister pack All batches APO-VALSARTAN valsartan 160 mg tablet blister pack All batches APO-VALSARTAN valsartan 320 mg tablet blister pack All batches
Why it was recalled
Trace amounts of an impurity, N nitrosodiisopropylamine (NDIPA), has been detected in batches of this product.
Hazard
N nitrosodiisopropylamine (NDIPA), is in the N nitroso chemical class that is known to contain mutagens and carcinogens (substances that could potentially cause cancer). However based on the information available to Apotex to date, the company has advised that it expects the health risk from use of affected APO-Valsartan tablets is very low.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.