Medicine recalls
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| Australia: Product defect correction: potential for blank labelling to pose risk of accidental misuse: Palexia SR 100 mg tapentadol sustained release tablets |
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Therapeutic Goods Administration (TGA) announces 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.
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.
Consumers are advised that if they, or a person they provide care for, uses Palexia 100 mg SR tablets, please check the batch number printed on the cardboard outer box. If they 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 they purchased them for a suitable replacement or refund.
Health professionals are advised that if they 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/palexia-sr-100-mg-tapentadol-sustained-release-tablets
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Feb 14, 2020
Issued at HKT 15:00
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