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TGA Action ID	RC-2020-RN-00490-1
Type of Product	Medicine
Product Name/Description	Novatin acitretin 10mg and 25 mg capsule blister pack Batch Numbers: A2568, A3143, A4246, A5158, A6252, A8177, A8534, A8900, A2765, A3136, A5197, A7144 Expiry: 30/11/2020, 31/01/2021, 19/02/2021, 30/04/2021, 30/11/2021, 30/04/2022, 31/08/2022, 30/04/2022, 31/10/2020, 31/01/2021, 2/05/2021, 28/02/2022 ARTG's 196006 (Novatin acitretin 10mg capsule blister pack) 96003 (Novatin acitretin 25mg capsule blister pack)
ARTG Number	196006
Action Type	Product Defect Correction
Action Level	Retail
Hazard Classification	Class I
Reason for the Action	The carton and blister foil include warnings not to become pregnant during use or within 24 months of stopping treatment. However, Apotex has now been made aware that this warning on the packaging is inconsistent with the warning in the current Apotex Product Information (PI) and Consumer Medicine Information (CMI) which is not to become pregnant during use or within 36 months of stopping treatment. Patients and caregivers supplied a pack of NOVATIN may not be aware of this anomaly between the label and the PI and CMI.
Instructions for Customers/Users	Pharmacists At the point of dispensing NOVATIN to female patients who are, or may become pregnant, please ensure that you make them (or their agent) aware of the correct pregnancy warning as stated below "Do not take Novatin if you are pregnant or intend to become pregnant during treatment or in 3 years after stopping treatment" Pharmacists are requested to obtain a customer signed copy of the “Acknowledgement Form” at the point of dispensing, for return to the sponsor Alternatively, if customers prefer to quarantine NOVATIN packs held in their pharmacy and return it to Apotex, please contact the Wholesaler to arrange for the return of the stock and a suitable refund will be applied Wholesalers Please Quarantine and return any units of NOVATIN (acitretin) 10mg or 25mg Capsules, 100’s currently under your control. Please return all affected stock to Apotex Pty Ltd This action has been reviewed and is considered complete in accordance with the requirements of the URPTG
Action Commencement Date	15/06/2020
Responsible Entity	Apotex Pty Ltd
Contact Information	1800 276 839 - Apotex Customer Service