Drug Recall

HPS Pharmacies wish to advise that Arrotex, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Avsartan^® as follows:

Avsartan^® Tablets
Irbesartan 150mg
ARTG 268774

Avsartan^® Tablets
Irbesartan 300mg
ARTG 268772

This recall has been initiated following the confirmation of trace amounts of AZBT [5-(4‘-(azidomethyl)-[1,1’-biphenyl]-2-yl)-1H-tetrazole] being present at levels higher than the acceptable level. AZBT is a chemical that can damage DNA and may increase the risk of cancer. However, the specific risk posed by AZBT to cause cancer in humans is unknown.

The following batches are affected:

• Avsartan^® 150mg – batches BRBG019 and IABG061
• Avsartan^® 300mg – batch IACG042

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Arrotex on 1800 276 839 or your pharmacist at HPS Pharmacies.