Vigabatrin (Sabril) 500 mg tablet: Supply issue resolved

The supplier recalled a single batch of vigabatrin (Sabril) 500 mg film-coated tablets (Batch number: 2007A | Pharmacode 2144697).

19 October 2023

Vigabatrin (Sabril) 500 mg film coated tablets are now back in stock following the July recall due to an impurity detected in one batch of the tablets.

People will need to change back to the tablets from the sachets. The clinical advice we have received says people should be able to switch between the tablets and sachets without any issues. We do acknowledge that changing someone's medicine can create anxiety for them and their caregivers.

Affected product

On 17 July 2023, the supplier wrote to wholesalers and pharmacists about a recall for a single batch of vigabatrin (Sabril) tablets. In consultation with Medsafe, the supplier recalled this batch because an impurity was detected. This recall is only to pharmacy level.

Medsafe Recall Notice(external link)

Details

  • Sabril brand vigabatrin
  • 500 mg film-coated tablets
  • Pharmacode: 2144697 
  • Expiry date: 11/2025
  • Batch number: 2007A

Schedule listing for Sabril(external link)

All other batches are unaffected by this issue. 

Tablets available again October 2023

Anyone who changed to the 500 mg sachets of vigabatrin will now have to change back to the tablets. The supply of sachets will not continue past what is already in the country. 

The clinical advice we have received says that people should be able to switch between the vigabatrin 500 mg tablets and the vigabatrin 500 mg sachets without any issues, however we acknowledge that changing a person’s medicine can create anxiety for them and their caregivers.

Pharmac will aim to delist the sachets in early 2024 to allow time for any remaining stock to be dispensed and claimed.

Who to contact

If you or a family member take vigabatrin and have concerns, you can

  • call Sanofi's medical information line on 0800 283 684 (0800 AVENTIS) option 2
  • talk to a trusted healthcare professional about what this recall will mean for you.  

If you are a pharmacist or wholesaler:

  • contact Sanofi for medical information 0800 283 684 option 2
  • contact Healthcare Logistics for information on stock or the affected batch details 0800 726 634

Medsafe(external link) is the agency responsible for ensuring the quality of medicines supplied in Aotearoa New Zealand. 

If you have any other questions, email enquiry@pharmac.govt.nz