Drug Recall for Palexia® SR 50mg

HPS Pharmacies wish to give notice that Seqirus, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Palexia^® SR as follows:

Palexia^® SR 50mg Tablets
Tapentadol (as hydrochloride) 50 mg
ARTG 165332

Products affected by this drug recall contain the lot number: 136V01 (Expiry 07/2026)

This drug recall was initiated following a hospital report that two tablets of different appearance were found in the same individual blister. The complainant reported that one of the tablets was stamped ‘H1’ and the other stamped ‘H2’. Palexia^® SR 50mg is a white tablet with a H1 stamp, while Palexia^® SR 100mg is a yellow tablet with a H2 stamp.

Please inspect your stock and quarantine any defect stock. 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, 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 Seqirus on 1800 008 275 or your pharmacist at HPS Pharmacies.
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