Safety information on the quality defect/recall of “Convulex 50 mg/ml - Sirup für Kinder” New
Precautionary batch recall, as there may be glass splinters in the bottles
A patient found glass fragments in the primary packaging when opening an originally sealed brown glass bottle of the medicinal product “Convulex 50 mg/ml - Sirup für Kinder” (marketing authorisation number 17.127, expiry date 31 December 2030). Therefore, it cannot be ruled out that additional bottles from the same batch are also affected and may contain glass fragments.
Currently, one batch (batch number M00651) of the affected product is on the Austrian market.
The marketing authorisation holder, G.L. Pharma GmbH, therefore initiated a precautionary recall on 29 May 2026.
Convulex 50 mg/ml - Sirup für Kinder (valproic acid) is for the treatment of primary generalised, secondary generalised and partial epileptic seizures. Convulex syrup is particularly suitable for treating young children (from 3 months of age), as its pleasant taste facilitates administration.
Measures at EU/national level
Nationally authorised product
Class 1 recall from the Austrian market
Situation in Austria
The marketing authorisation holder G.L. Pharma GmbH is conducting a recall of batch M00651 in Austria.
The affected batch has an expiry date of 31 December 2030.
The BASG has not received any reports of adverse reactions from Austria during the period in which the batch was distributed.
Recommendations of the BASG
Recommendations for Patients:
If you have received a pack of the medicinal product “Convulex 50 mg/ml - Sirup für Kinder” of batch M00651 from your doctor or pharmacist, please do not continue to use it, as it may contain glass splinters.
Packs from batch M00651 can be returned to any pharmacy in Austria.
If you have any questions or concerns, please contact your pharmacist or doctor.
Inquiries (technical):
Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004
E-Mail: christoph.baumgaertel@ages.at
Inquiries (for media):
Kommunikationsmanagement, Tel.: +43 505 55-25000
E-Mail: presse-basg@basg.gv.at
| Name of the medicinal product | Convulex 50 mg/ml - Sirup für Kinder |
|---|---|
| Marketing authorisation number(s) | 17.127 |
| CIP code | 0678707 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | M00651 |
| Expiry date | 12/31/2030 |
| BASG reference number | INS-640.001-5697 |
| Further information Link | Recall "Convulex 50 mg/ml - Sirup für Kinder" |
