Print version of this report
Type of Product Medicine
TGA Recall Reference RC-2017-RN-00144-1
Product Name/Description Boostrix, Havrix, Twinrix, Typherix, Varilrix Vaccines

Boostrix, pre-filled syringe
Batch No. AC37B234AB
AUST R: 158363

Havrix, pre-filled syringe
Batch No. AHAVB878AA
AUST R: 147331

Havrix Jnr, pre-filled syringe
Batch No. AHAVB910CB
AUST R: 147335

Twinrix, pre-filled syringe
Batch No. AHABB351AZ
AUST R: 140575

Typherix, pre-filled syringe
Batch No. ATYPB120BC
AUST R: 68500

Varilrix, vial + diluent
Batch No. A70CC978A
AUST R: 234750
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 30/01/2017
Responsible Entity GlaxoSmithKline Australia Pty Ltd
Reason/Issue GlaxoSmithKline (GSK) has identified that a temperature excursion has occurred during transit on a consignment delivered to Perth between the 10th to the 14th of January 2017, which products from this consignment was subsequently onward distributed to pharmacies by a single wholesaler. Whilst there were no manufacturing defects with these products, temperature excursions may impact the efficacy of these products. GSK Australia is undertaking a recall of the affected stock (only a subset of the above batches are affected) from the impacted wholesaler and pharmacies.
Recall Action Recall
Recall Action Instructions GSK Australia has notified the impacted wholesaler, pharmacies and medical centres of the issue. They have been asked to inspect their vaccines stock, isolate and not to distribute any of the vaccines from the affected stock. GSK will arrange for collection of the stock of the implicated vaccines. If any of the affected stock has been used, GSK medical assessment supports re-vaccination. Only 6 dispensed affected units have been administered to patients. All other units from the affected stock remains in quarantine ready to be recalled.
This action has been closed-out on 16/03/2018.
Contact Information 1800 033 109 - GSK Medical Information