CARVEDILOL SANDOZ carvedilol 6.25 mg tablets blister pack, Sandoz Pty Ltd, CON-1263
Product name
CARVEDILOL SANDOZ carvedilol 6.25 mg tablets blister pack
Sponsor name
Sandoz Pty Ltd
Batches
NP2173
Consent start
Consent no.
CON-1263
Duration
The consent is effective from 14 August 2024 until 28 February 2025.
Standard
Paragraphs 10(14)(a)(vii) and 10(14)(a)(viii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product blister pack does not contain the batch number of the medicine
preceded by the batch number prefix and the expiry date of the medicine preceded
by the expiry date prefix.
Conditions imposed
The sponsor will provide a ‘Dear Pharmacist’ letter with each affected batch,
advising pharmacists to remind patients to keep the blister packs with the
correctly labelled carton with each of the affected batches (the letter must
be identical to that provided to the TGA on 26 April 2024).
Therapeutic product type
Prescription medicines