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Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall

Published: February 18, 2020Recall ID: 3b15bd70-050e-43df-9423-f57815115facCategory: generalCountry: Australia

Reason for Recall / Hazard

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.

Product Description & Identification

Reason / 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. 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 to 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.

Affected Products

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.

Additional Source Details

FieldValue
Guid › #text3b15bd70-050e-43df-9423-f57815115fac
Guid › @ is Perma Linkfalse
Linkhttps://www.productsafety.gov.au/search-consumer-product-recalls/palexia-sr-100mg-tapentadol-as-hydrochloride-sustained-release-tablets-expanded-recall
Pub DateTue, 18 Feb 2020 00:00:00 +0000
Extracted imagehttps://www.productsafety.gov.au/system/files/styles/large/private/Palexia%20SR%20100mg%20tapentadol%20sustained%20release%20tablets%20front%20label.png?itok=sfdr_Qqc

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Overview

  • Risk LevelPharmacy and medical products
  • DistributionAustralia
Recall Hazard Severity
Caution (Class III)
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