Apotex Recalls APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets -- Australian Recalls

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

PRA No.

2018/17229  Date published

7 Jan 2019

Campaign number

RC-2018-RN-01525-1

 

 

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

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...(link is external) or contact Apotex Customer Service on 1800 276 839

Supplier

Apotex Pty Ltd(link is external)

Traders who sold this product

Chemists, Pharmacies, Hospitals and Pharmaceutical Wholesalers

Where the product was sold

Nationally

Dates available for sale

• 9 July 2018 - 27 November 2018

Recall advertisements and supporting documentation

Recall Advertisement.pdf (50.59 KB)

Responsible regulator

Therapeutic Goods Administration(link is external) is the responsible regulator for this recall.