TGA issues product defect correction


Pharmacists are advised that Janssen is undertaking a product defect correction for one batch of Jurnista (hydromorphone hydrochloride) prolonged-release blister packs

Janssen, following consultation with the TGA, is undertaking a product defect correction for one batch of Jurnista (hydromorphone hydrochloride) prolonged-release blister packs (8 mg, 14 tablets) due to potential damage to the tablets.

A misalignment issue with a packaging machine resulted in damage to the outer coating on some tablets in the affected batch. This damage may affect the release rate of the medicine.

The affected batch number is IALS400 with an expiry date of 12-2019.

“Only a small proportion of this batch is potentially affected by this issue,” says the TGA.

An affected blister pack with damaged tablets.

 

Examples of damaged tablets after their removal from the packaging.

 

The batch number and expiry date are printed on the end tab of the box.

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.

The physical damage to affected tablets is obvious and it is likely that a patient or caregiver would notice and seek advice before the product is consumed. There have been no Australian adverse events reported to the TGA due to this issue.

“There is no quality issue with tablets that have not been physically damaged and, due to the need to maintain continuous analgesia in patients who are taking Jurnista, this issue is being addressed through a consumer level product defect correction, rather than a recall,” says the TGA.

If a patient takes one of the damaged tablets there are two potential risks:

  • Tablet ‘pre-activation’ resulting in faster-than-intended absorption of the active ingredient, potentially resulting in overdose and lack of steady-state condition; or
  • Active ingredient degradation due to exposure to oxygen, potentially resulting in under-dosing.

Janssen has written to pharmacists providing more details about this issue and the product defect correction process.

It advises pharmacists who have stock on hand from batch IALS400 to quarantine the product, then open the box and check for any damage to the blister pack. If there is damage, Janssen advises pharmacists to contact their wholesaler to arrange for the return of the product.

If there is no damage pharmacists are advised to re-tape the end tab (initialling the reseal by hand), after which the product may be dispensed as usual, in conjunction with suitable patient counselling.

Janssen has asked pharmacists who have dispensed Jurnista 8 mg from batch number IALS400, or those who are unsure of the batch number dispensed, to contact all customers who have been dispensed Jurnista 8 mg 14 tablet pack, since 5 December 2018 and supply them with information contained in the letter to pharmacists.

If a pharmacist has any questions or concerns about this issue, contact Janssen’s Medical Information Department on 1800 226 334.

Please note that no other Jurnista presentation is affected by this issue.

Consumers have been advised to check their 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. 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 a consumer has any questions or concerns about this issue, they are encouraged to speak to their doctor or pharmacist. They may also contact Janssen’s Medical Information Department on 1800 226 334.

Read the full TGA alert here

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