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APO-Valsartan 40 mg 80 mg 160 mg 320 mg tablets

Official notice

7 Jan 2019

Last checked

7 Jan 2019

Risk not stated by sourceACCC

An official ACCC notice concerns APO-Valsartan 40 mg 80 mg 160 mg 320 mg tablets. 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. Published 2019-01-07.

What to do now

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

Recall number

55a14af5-e516-4079-8f65-f832e75366e4

Official notice

2019-01-07

The 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.

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Affected products

Product 1

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

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

unspecified

Recall details

Recall number

55a14af5-e516-4079-8f65-f832e75366e4

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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