Safety information on the quality defect/recall of "Amoxilan 250 mg/5 ml - Trockensaft" New
Precautionary batch recall as a glass splinter was discovered in a 60 ml bottle
The Federal Office for Safety in Health Care (BASG) has received a report that an approx. 1 cm glass splinter was found in the glass bottle in a pharmacy during the preparation of dry juice. The bottle was intact, so it is suspected that glass splinters may have entered the medicine bottles during the production process. As a result, the manufacturer's investigation into the cause revealed that damage caused by moving components in the area of the dosing unit during filling could not be ruled out.
The defect could be narrowed down to only one batch (23K11) for the Austrian market and only affects the 60 milliliter (60 ml) bottles, but not the 120 ml bottles.
"Amoxilan 250 mg/5 ml - Trockensaft" (amoxicillin) has been authorized for the treatment of infections caused by amoxicillin-susceptible pathogens since 16.09.1994 by means of generic application (Article 10(1) of Directive No 2001/83/EC). 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 10 days in the 60 ml bottle.
Measures at EU/national level
Nationally approved medicinal product
Class I recall from the Austrian market
Situation in Austria
The marketing authorization holder G.L. Pharma GmbH is conducting a recall for batch 23K11 in Austria.
The recall only concerns the "Amoxilan 250 mg/5 ml - Trockensaft" in the 60 ml bottles (the 120 ml bottles are not affected)
The batch was placed on the market from January 08, 2024 to April 09, 2024. 5,004 packs have already been sold. The affected batch has an expiry date of 10/2026.
Recommendations of the BASG
Recommendations for patients:
If you have received a pack of the named proprietary medicinal product "Amoxilan 250 mg/5 ml - Trockensaft" of batch 23K11 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 23K11 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 250 mg/5 ml - Trockensaft |
|---|---|
| Marketing authorisation number(s) | 1-20613 |
| CIP code | 1286346 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | 23K11 |
| Expiry date | 10/31/2026 |
| BASG reference number | INS-640.001-4717 |
| Further information Link | Recall "Amoxilan 250 mg/5 ml - Trockensaft" |
