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Type of Product	Medicine
TGA Recall Reference	RC-2017-RN-01406-1
Product Name/Description	APO-Perindropril Arginine 2.5mg, AUST R: 184808 Batch NC6619 Exp: 02/2020 NC6620 Exp: 05/2020 MX1699 Exp: 05/2019 MX1698 Exp: 05/2019 MX1697 Exp: 05/2019 APO-Perindropril Arginine 5mg, AUST R: 184806 Batches NC6671 Exp: 03/2020 NC6670 Exp: 03/2020 NC6672 Exp: 03/2020 MX1700 Exp: 05/2019 MX1701 Exp: 05/2019 MX1702 Exp: 05/2019 APO-Perindropril Arginine 10mg, AUST R: 184812 Batches MX1705 Exp: 05/2019 MX1704 Exp: 05/2019 MX1703 Exp: 05/2019 NC6729 Exp: 03/2020
Recall Action Level	Consumer
Recall Action Classification	Class III
Recall Action Commencement Date	10/11/2017
Responsible Entity	Apotex Pty Ltd
Reason/Issue	EXPANDED Apotex Pty Ltd has initiated a recall of the above batches of APO-Perindopril Arginine tablets after reports of dark-coloured particles leaking from the desiccant cylinder inside the bottles. This potential contamination represents a quality defect but does not impact on product safety or efficacy. Eight additional batches have been added to this recall on 14/11/17, on top of the three agreed to on 10/11/2017
Recall Action	Recall
Recall Action Instructions	Wholesalers, Pharmacists and Consumers are asked to inspect their holdings of APO-Perindopril Arginine and quarantine all units from the given batch numbers. In the event affected stock is found, Wholesalers and Pharmacists are requested to complete the Facsimile Reply Form supplied by Apotex with the Recall Letter and to fax or email the completed form back to Apotex as per the instructions given. Please return the Facsimile Reply Form even if you do not have stock which is subject to this recall action, as Apotex requires this information to reconcile the process. Consumers are asked to return any supplies with the listed batch numbers to their Pharmacy for a replacement or refund. A new prescription may be required. For further information please see https://www.tga.gov.au/alert/apo-perindopril-arginine This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 276 839 - Apotex Customer Service