Product Defect Correction
HPS Pharmacies wish to advise that Seqirus, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect correction for Palexia® SR 100mg tablets as follows:
Palexia® SR 100mg Tablets
Tapentadol 100 mg
The only batch affected by this action is 985P01 with an expiry date of January 2022.
This action has been initiated following the identification of printing anomalies in some packages of Palexia® SR 100mg from the abovementioned batch. Affected products may contain blister strips with the printed product details being either faded or missing. The absence of identifying details on the blister strip may increase the risk of product selection errors, particularly for patients prescribed more than one strength of Palexia® tablets. This issue is not apparent until the carton is opened and the blister strips inspected.
This is a packaging issue only. The quality of the medicine contained within is not affected. Unaffected blister strips may continue to be used as normal.
Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Seqirus on 1800 008 275.