OECDReference EN/AU/PS1080318
Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall
Official information
Risk and measures
- Risk or 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. 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.
- Recommendations
- 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.
Official information
Economic operators
- Manufacturer
- Seqirus Pty Ltd
Territory
Geography
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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