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Palexia SR 100 mg tapentadol sustained release tablets

Product defect correction - potential for blank labelling to pose risk of accidental misuse

14 February 2020

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.

The product details on some blister strips may be faded or missing.

A pack of Palexia SR 100 mg tablets

A pack of Palexia SR 100 mg tablets.

The batch number is printed on the end of the carton. The affected batch is 985P01.

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.

For further information call Seqirus Customer Service on 1800 008 275.

Information for consumers

If you, or a person your provide care for, uses Palexia 100 mg SR tablets please check the batch number printed on the cardboard outer box. If you have a pack from batch 985P01 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.

If you have any questions call Seqirus Customer Service on 1800 008 275.

Information for health professionals

Ensure all relevant staff members are informed of this recall for product correction, including relevant clinicians who may decide to monitor for adverse events, as applicable.

If you are treating patients who use Palexia 100 mg SR tablets counsel them to be alert to this issue.

Prior to dispensing a pack from batch 985P01, pharmacists should inspect the individual blister strips to verify that the print is clear. Unaffected strips may continue to be dispensed as normal.

As a precautionary measure, this batch is also being recalled from wholesalers to mitigate against any residual risk for stock in the market.

A medicine shortage is unlikely.

If you need more information about the recall process call Seqirus Customer Service on 1800 008 275.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.