| 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 |
|
| 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 |