Batch recall: Epirubicin AqVida 2 mg / ml solution for injection, 10 mg / 5 ml, 50 mg / 25 ml and 200 mg / 100 ml vial
Batch recall: Epirubicin AqVida 2 mg / ml solution for injection, 10 mg / 5 ml, 50 mg / 25 ml and 200 mg / 100 ml vial
Hamburg / Dassow, July 12th, 2021
Epirubicin AqVida 2 mg / ml solution for injection
10 mg / 5 ml vial
Ch.-B.: BX200201, BX200202, BX200203
Epirubicin AqVida 2 mg / ml solution for injection
50 mg / 25 ml vial
Ch.-B.: BK200201, BK200202, BK200203, BK200204
Epirubicin AqVida 2 mg / ml solution for injection
200 mg / 100 ml vial
Ch.-B.: BM200201, BM200301
During a marketing-accompanying stability study, an OOS (Out of Specification) content was determined on a batch at the time of testing for 12 months. In the course of researching the cause of this OOS, a production-related inhomogeneity of the content of other batches could not be ruled out.
Due to this lack of quality, the above-mentioned batches of the drug Epirubicin AqVida 2 mg / ml injection solution, 10 mg / 5 ml, 50 mg / 25 ml and 200 mg / 100 ml vials (PZN 14279595, 14279603, 14279632), at wholesale and pharmacy level called back.
Please use the reply fax to inform us how many packs of the affected batches you still have in your inventory. After consultation with you, we will arrange for the packaging concerned to be picked up. You will then receive a corresponding replacement delivery.
The serialization numbers of all affected packs are already blocked from being dispensed in the securPharm system. Furthermore, we ask you to inform the supplied institutions about the batch recall.
AqVida GmbH Premium Oncology ProductsQuality - Made in Germany
We are available for current company topics and interview requests:
Saskia Heinze
Claudia Schubert
Phone: +49 (0) 40 / 380 371 9 - 0
Mail: pr@aqvida.com
Hamburg / Dassow, July 12th, 2021
Epirubicin AqVida 2 mg / ml solution for injection
10 mg / 5 ml vial
Ch.-B.: BX200201, BX200202, BX200203
Epirubicin AqVida 2 mg / ml solution for injection
50 mg / 25 ml vial
Ch.-B.: BK200201, BK200202, BK200203, BK200204
Epirubicin AqVida 2 mg / ml solution for injection
200 mg / 100 ml vial
Ch.-B.: BM200201, BM200301
During a marketing-accompanying stability study, an OOS
(Out of Specification) content was determined on a batch at the time of testing for 12 months. In the course of researching the cause of this OOS, a production-related inhomogeneity of the content of other batches could not be ruled out.
Due to this lack of quality, the above-mentioned batches of the drug Epirubicin AqVida 2 mg / ml injection solution, 10 mg / 5 ml, 50 mg / 25 ml and 200 mg / 100 ml vials (PZN 14279595, 14279603, 14279632), at wholesale and pharmacy level called back.
Please use the reply fax to inform us how many packs of the affected batches you still have in your inventory. After consultation with you, we will arrange for the packaging concerned to be picked up. You will then receive a corresponding replacement delivery.
The serialization numbers of all affected packs are already blocked from being dispensed in the securPharm system. Furthermore, we ask you to inform the supplied institutions about the batch recall.
AqVida GmbH Premium Oncology ProductsQuality - Made in Germany
We are available for current company topics and interview requests:
Saskia Heinze
Claudia Schubert
Phone: 49 (0) 40 / 380 371 9 - 0
Mail: pr@aqvida.com