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

Official notice

18 Feb 2020

Last checked

18 Feb 2020

Low riskACCC

An official ACCC notice concerns Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall. 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. Published 2020-02-18.

What to do now

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.

Recall number

3b15bd70-050e-43df-9423-f57815115fac

Official notice

2020-02-18

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

/expiry, es, 986P01, 985P01, printed

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Affected products

Product 1

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.

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

low

Recall details

Recall number

3b15bd70-050e-43df-9423-f57815115fac

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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