ZOLPIBELL Zolpidem tartrate 10 mg tablet blister pac, Generic Health Pty Ltd, CON-1141
Product name
ZOLPIBELL Zolpidem tartrate 10 mg tablet blister pac
Sponsor name
Generic Health Pty Ltd
Batches
2300691C and 2103714B
Consent start
Consent no.
CON-1141
Standard
Subparagraph 10(14)(a)(v) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) have the incorrect active ingredient name on the blister packs,
which include the name zolpibell tartrate instead of zolpidem tartrate.
Conditions imposed
A 'Dear Pharmacist' letter identical to that provided to the Therapeutic Goods
Administration on 24 July 2023 advising them to remind patients to keep the
blister packs with the correctly labelled carton, must be provided with each of
the affected batches.
Therapeutic product type
Prescription medicines