Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall
Published 18 February 2020
Product
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.
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.