PRA number
2020/18188
Published date
Product description
Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets
Blister strips
Batches 985P01 and 986P01
Expiry Date 31/01/2022
This recall has been expanded to include Batch 986P01 from 20 March 2020.
AUST R 165346
Palexia SR is used in the management of moderate to severe chronic pain in patients who meet certain criteria.
Blister strips
Batches 985P01 and 986P01
Expiry Date 31/01/2022
This recall has been expanded to include Batch 986P01 from 20 March 2020.
AUST R 165346
Palexia SR is used in the management of moderate to severe chronic pain in patients who meet certain criteria.
Reasons the product is recalled
Blister strips may have faded or missing labelling relating to the batch number or expiry details. The recall is only because of a labelling issue. The quality of the product is not affected.
The hazards to consumers
The absence of product and batch/expiry details on the blister strips compromises the identity of the product and could present a risk of product mix-up and overdose, especially when the same patient is using more than one strength of medicine on any given day.
What consumers should do
If you, or a person your provide care for, uses Palexia SR 100mg tablets, please check the batch number printed on the cardboard outer box (on the end of the carton). If you have a pack from either batch 985P01 or 986P01, check the individual blister strips to ensure the product details are fully legible.
If the blister strips are affected by this printing issue, return those strips to the pharmacy where you purchased them for a suitable replacement or refund.
For further information, call Seqirus Customer Service on 1800 008 275.
If the blister strips are affected by this printing issue, return those strips to the pharmacy where you purchased them for a suitable replacement or refund.
For further information, call Seqirus Customer Service on 1800 008 275.
Supplier
Traders who sold this product
Pharmacies and Chemists
Where the product was sold
Nationally
Dates available for sale
-
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.