Janssen-Cilag Pty Ltd — Jurnista Hydromorphone Hydrochloride 8 mg Prolonged Release Tablet Blister Pack

PRA number

2019/17345

Published date

Product description

Jurnista hydromorphone hydrochloride 8 mg prolonged release
14 tablet blister pack
AUST R: 141508
Product Number: AN412056

Batch Number: IALS400
Expiry date: Dec 2019

Jurnista is prescribed for patients with chronic, constant pain that is moderate to severe and expected to be long-lasting. It can only be prescribed by a doctor.
Identifying features

Other identifying numbers

Batch IALS400, Expiry Date Dec 2019

What are the defects?

A manufacturing issue with some blister packs has resulted in damage to the outer coating of some tablets.

What are the hazards?

Damage to the outer coating of the tablets may affect the release rate or dosage of the medicine.

What should consumers do?

Check your Jurnista packaging to see if you have any tablets from batch number IALS400. If so, check the blister packs and tablets for any signs of damage (do not remove tablets from the packaging unless they are going to be consumed straight away). If the blister pack or tablets are damaged do not consume them. Return the entire Jurnista box to your dispensing pharmacy to discuss replacement options.

In the likely event that the blister pack and tablets are not damaged, you should continue to take the medication as prescribed by your doctor.

If you have any questions or concerns about this issue, talk to your doctor or pharmacist. You may also contact Janssen's Medical Information Department on 1800 226 334 or email medinfo@janau.jnj.com

Where the product was sold

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category