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.

See a list of details to help identify the product.

Reason the product is recalled

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

The hazards to consumers

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

What consumers should 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

Details to help identify the product.

Supplier running the recall

Identifying numbers

Other identifying numbers

Batch IALS400, Expiry Date Dec 2019

Where the product was sold

Nationally

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2019/17345 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.