Seqirus Pty Ltd — Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall

Photograph of Palexia SR 100mg tapentadol sustained release tablets front label
Photograph of Palexia SR 100mg tapentadol sustained release tablets  end of packaging with batch number
Photograph of Palexia SR 100mg tapentadol sustained release tablets foil blister pack

Identifying features

Other
Batch 985P01 and 986P01

What are the defects?

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.

What are the hazards?

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 should consumers 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.

Traders who sold this product

Pharmacies and Chemists

Where the product was sold
Nationally
Dates available for sale
  • 12 November 2019 - 15 January 2020

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category