Print version of this report
Type of Product Medicine
TGA Recall Reference RC-2021-RN-01640-1
Product Name/Description AVSARTAN Irbesartan tablet 150mg and 300mg.

Batch numbers: BRBG019, IABG061 and IACG042

Expiry dates: May 2023, August 2023 and September 2023

ARTG 268774
(AVSARTAN irbesartan 150mg film-coated tablet blister pack)
ARTG 268772
(AVSARTAN irbesartan 300mg film-coated tablet blister pack)
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 9/08/2021
Responsible Entity Arrow Pharma Pty Ltd
Reason/Issue Arrotex were made aware of the potential for the azido impurity to be present in batches of AVSARTAN. The azido impurity occurs during the manufacturing process and has potential mutagenic properties. Three batches were identified as having amounts of the impurity, AZBT [5-(4‘-(azidomethyl)-[1,1’-biphenyl]-2-yl)-1H-tetrazole] present at above the acceptable level.

To date, Arrotex has not received any complaints or adverse event reports.
Recall Action Recall
Recall Action Instructions Wholesalers:
Wholesalers are advised to inspect and quarantine all impacted product to prevent further use.
Arrotex is asking distributors to receive returned stock from pharmacies and then forward the affected stock to Arrotex.

Retailers:
Retailers are advised to inspect and quarantine all impacted product to prevent further use. Retailers are to contact wholesalers to arrange for the return of the stock and a suitable refund will be applied.
Contact Information 1800 276 839 - Arrotex Customer Service