Safety information on the quality defect/recall „BRONCHOSTOP Erkältungssaft“
Due to a complaint in the Netherlands about glass splinters in a bottle, the batch 0K7192 of the medicinal product "BRONCHOSTOP Erkältungssaft" (registration number 739029, expiry date 10/2023) placed on the market in Austria must also be recalled.
The same batch of bottles was used for this Austrian batch.
The marketing authorisation holder "Kwizda Pharma GmbH" initiated a precautionary recall on December 29, 2022.
Other batches of "BRONCHOSTOP Erkältungssaft" or another medicinal product from this marketing authorisation holder are not affected.
The BASG has not received any adverse reaction notifications for the affected batch from Austria during the period of marketing in question (22.03.2022 to 22.12.2022).
Recommendations of the BASG
Recommendations for healthcare professionals:
Patients can return packs of batch 0K7192 of the medicinal product "BRONCHOSTOP Erkältungssaft" to all Austrian pharmacies. Replacement goods are available.
Recommendations for patients:
Packs of batch 0K7192 of the medicinal speciality "BRONCHOSTOP Erkältungssaft" can be returned to all Austrian pharmacies.
If you have any questions or feel unsure, please contact your pharmacy, your doctor or your health care professional.
Please report all adverse reactions related to "BRONCHOSTOP Erkältungssaft" to the Federal Office for Safety in Health Care/AGES Medical Market Surveillance.
Enquiries (technical):
Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004
E-Mail: christoph.baumgaertel@ages.at
Enquiries (for media):
Kommunikationsmanagement, Tel.: +43 505 55-25000
E-Mail:presse-basg@basg.gv.at
| Name of the medicinal product | BRONCHOSTOP Erkältungssaft |
|---|---|
| Marketing authorisation number(s) | 739029 |
| CIP code | 4969755 |
| Marketing authorisation holder | Kwizda Pharma GmbH |
| Batch number(s) | 0K7192 |
| Expiry date | 10/31/2023 |
| BASG reference number | INS-640.001-4136 |
| Further information Link | Recall BRONCHOSTOP Erkältungssaft |
