Recall published

Topics

Cosmetic and health products
Pharmacy and medical products

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

See a list of details to help identify the product

Reason 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-valsartan-product-recall or contact Apotex Customer Service on 1800 276 839

Details to help identify the product

Supplier running the recall

Apotex Pty Ltd

Who sold the product

Chemists, Pharmacies, Hospitals and Pharmaceutical Wholesalers

Identifying numbers

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)

Dates available for sale

-

Where the product was sold

Nationally

Print supporting information

Recall Advertisement.pdf 50.59 KB

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2018/17229 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.