Vigabatrin (Sabril) 500 mg tablet: Recall and supply issue
The supplier is recalling a single batch of vigabatrin (Sabril) 500 mg film-coated tablets (Batch number: 2007A | Pharmacode 2144697).
21 September 2023 update
The vigabatrin sachets are now Medsafe approved, gazetted 21 September 2023. The section 29 endorsement will be removed from the Schedule from 1 October 2023.
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 is recalling 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.
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