Safety information on the quality defect/recall of „Amoxilan 500 mg/5 ml – Trockensaft“
Precautionary batch recall, as there may be glass splinters in the 60 ml bottles
In a pharmacy, a part of the neck of the bottle (glass) was found to be broken off while preparing the medicinal product “Amoxilan 500 mg/5 ml - Trockensaft” (Authorisation number 1-20614, expiry date 03/2027). The whereabouts of the broken piece is unknown. However, the bottle cap itself was intact and there is no indication of user error or transportation damage. It is therefore suspected that the neck of the bottle was damaged during manufacturing (during filling) and that there may be glass fragments in the other bottles of the affected batch.
The defect could be narrowed down to only one batch (batch number 24L19) for the Austrian market and only affects the 60 milliliter (60 ml) bottles, but not the 120 ml bottles.
The marketing authorisation holder “G.L. Pharma GmbH” has therefore initiated a precautionary recall on March 05, 2025.
Amoxilan 500 mg/5 ml - Trockensaft (amoxicillin) has been approved since September 16, 1994, for the treatment of infections caused by pathogens sensitive to amoxicillin. The juice is prepared exclusively by pharmacists or doctors. The juice is then dispensed to patients for independent ingestion. The shelf life of the prepared juice is 14 days in the 60 ml bottle.
Measures at EU/national level
Nationally approved medicinal product
Class 1 recall from the Austrian market
Situation in Austria
The marketing authorisation holder “G.L. Pharma GmbH” is conducting a recall for batch 24L19 in Austria.
The recall only affects the Amoxilan 500 mg/5 ml - Trockensaft in the 60 ml bottles (the 120 ml bottles are not affected).
The batch was placed on the market from July 02, 2024, to February 25, 2025. 3,202 packs have already been sold. The affected batch has an expiry date of March 31, 2027.
Recommendations of the BASG
Recommendations for patients:
If you have received a pack of the named proprietary medicinal product Amoxilan 500 mg/5 ml - Trockensaft of batch 24L19 in a 60 ml bottle from your doctor or pharmacist, please do not continue to use it, as it may contain glass splinters. Packs of batch 24L19 can be returned to all Austrian pharmacies.
If you have any questions or feel unsure, please contact your pharmacy or doctor.
Enqueries (technical):
Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004
E-Mail: christoph.baumgaertel@ages.at
Enqueries (for media):
Kommunikationsmanagement, Tel.: +43 505 55-25000
E-Mail: presse-basg@basg.gv.at
| Name of the medicinal product | Amoxilan 500mg/5ml - Trockensaft |
|---|---|
| Marketing authorisation number(s) | 1-20614 |
| CIP code | 1286369 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | 24L19 |
| Expiry date | 03/31/2027 |
| BASG reference number | INS-640.001-5099 |
| Further information Link | Recall „Amoxilan 500mg/5ml – Trockensaft“ |
