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

PRA number

2018/17229

Campaign number

RC-2018-RN-01525-1

Published date

Product description

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
Identifying features

Barcode number

9338475068395 (40 mg); 9338475068548 (80 mg); 9338475068692 (160 mg); 9338475068845 (320 mg)

Other identifying numbers

AustR 185806 (40 mg); 185814 (80 mg); 185821 (160 mg); 185826 (320 mg)

Reasons the product is recalled

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





The hazards to consumers

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 consumers should 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-valsarta… or contact Apotex Customer Service on 1800 276 839

Supplier

Apotex Pty Ltd

Traders who sold this product

Chemists, Pharmacies, Hospitals and Pharmaceutical Wholesalers

Where the product was sold

Nationally

Dates available for sale

-

Recall advertisements and supporting documentation

Recall Advertisement.pdf 50.59 KB

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

Pharmacy