Apotex Pty Ltd — APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets

Identifying features

Barcode number
9338475068395 (40 mg); 9338475068548 (80 mg); 9338475068692 (160 mg); 9338475068845 (320 mg)
AustR 185806 (40 mg); 185814 (80 mg); 185821 (160 mg); 185826 (320 mg)

What are the defects?

Trace amounts of an impurity, N nitrosodiisopropylamine (NDIPA), has been detected in batches of this product.

What are the hazards?

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.

What should consumers do?

Return any unused APO Valsartan to your pharmacy for a refund. You should be offered an alternative brand or referred to your doctor if an alternative treatment is required.

Please consult your doctor or pharmacist before stopping or changing your medication.

For further information please see http://www1.apotex.com/au/about-us/press-centre/2018/12/17/apo-valsartan... or contact Apotex Customer Service on 1800 276 839

Traders who sold this product

Chemists, Pharmacies, Hospitals and Pharmaceutical Wholesalers

Where the product was sold
Dates available for sale
  • 9 July 2018 - 27 November 2018

Recall advertisements and supporting documentation

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category