Urgent Medicine Recall: Palexia SR Tapentadol 50 mg Tablets - TGA Notice
The Therapeutic Goods Administration (TGA) has issued an urgent medicine recall for Palexia SR tapentadol (as hydrochloride) 50 mg sustained release tablet blister pack.
The product sponsor has been informed of a complaint from a hospital regarding Palexia (tapentadol) SR 50 mg tablets. Two tablets from the same blister were found to differ in both colour and stamp markings — one was a white tablet marked with 'H1,' while the other was beige and marked with 'H2.' Palexia SR 100 mg tablets are yellow with a 'H2' stamp.
Product Details:
- Lot number: 136V01
- Expiry: July 2026
- ARTG: 165332
- Sponsor: Seqirus Pty Ltd
Pharmacies are advised to:
- Inspect stock immediately
- Quarantine all impacted stock for the mentioned lot/batch number
- Capture images of the affected stock
- Destroy stock as per the relevant legislation and maintain a record of destruction
- Replacement stock will be issued by the sponsor.
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