A labelling problem has seen Seqirus undertake a product defect correction over one batch of Palexia
The TGA has advised consumers and health professionals that in consultation with the TGA, the company has undertaken a product defect correction involving a batch of Palexia 100mg 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,” the TGA warns.
“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 100mg, or any other Palexia products.
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.
More information is available from Seqirus Customer Service on 1800 008 275.
The TGA advised patients to bring affected strips back to the pharmacy of purchase for a suitable replacement or refund.
Health professionals are advised to 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.
“Prior to dispensing a pack from batch 985P01, pharmacists should inspect the individual blister strips to verify that the print is clear,” the TGA says.
“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.”