Consumers and health professionals are advised that Seqirus, in consultation with the TGA, is undertaking a product defect correction involving one batch of Palexia 100 mg sustained-release (SR) tapentadol tablets due to a labelling fault.
Some packages of Palexia 100 mg SR tablets from batch 985P01 may contain blister strips with the printed product details either being faded or missing. This anomaly is not apparent until the carton is opened and the blister strips are inspected.
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.
The issue does not affect any other batches of Palexia SR 100 mg, or any other Palexia products.
Palexia SR is used in the management of moderate to severe chronic pain in patients who meet certain criteria.
The product details on some blister strips may be faded or missing.
A pack of Palexia SR 100 mg tablets.
The batch number is printed on the end of the carton. The affected batch is 985P01.
Batch 985P01 was distributed to medical wholesalers and distributors between 12 November 2019 and 15 January 2020. The issue only affects the packaging and the quality of the medicine contained within it is unchanged.
