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BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle, Pfizer Australia Pty Ltd, CON-1209
Product name
BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1209
Duration
The consent is effective for all batches of the products released from 1 February 2024 until 31 January 2025.
Standard
Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not include a declaration for the Schedule 1 substance ‘Soya
bean products’ on the carton labels and incorrectly states benzoates in place of
hydroxybenzoates.
Conditions imposed
A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutics Goods Administration on 25 January 2024 will be supplied with each
affected batch warning of the presence of lecithin derived from Soya Bean
Products but there is no change to the product.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines