FLUANXOL DEPOT flupentixol decanoate 40 mg/2 mL injection ampoule, Lundbeck Australia Pty Ltd, CON-780
Product name
FLUANXOL DEPOT flupentixol decanoate 40 mg/2 mL injection ampoule
Sponsor name
Lundbeck Australia Pty Ltd
Batches
2682447, 2680047
Consent start
Consent no.
CON-780
Standard
Paragraph 8(1)(n) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not conform with the requirements of paragraph
8(1)(n) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription
and related medicines (TGO 91) in that the carton labels for the above mentioned
batches include the incorrect Global Trade Item Number (GTIN) code in the 2D
matrix and consequently, the GTIN codes within the 2D matrix and linear barcode
on the carton are not identical.
Conditions imposed
A 'Dear Healthcare Provider' letter (as per the copy provided with the
application) will be supplied with the affected batches outlining the non
-compliance.
Therapeutic product type
Prescription medicines