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 |
|
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 |