Following an increased number of reports of anaphylactic reactions in horses after the administration of Genta-Equine 100 mg/ml, two batches are being recalled in Belgium. These are batches T-001 (expiry date 30 April 2025) and V-001 (expiry date 30 April 2026).
Following our communication of 31 January 2025, the FAMHP informs that a recall of batches T-001 and V-001 of Genta-Equine 100 mg/ml solution for injection for horses, has been initiated by Dechra as distributor and Franklin Pharmaceuticals Ltd. (Ireland) as marketing authorisation holder. As a result of this recall, the Direct animal Healthcare Professional Communication (DaHPC) is being replaced by a recall letter.
An increase in the frequency of clinical signs, including signs of colic/abdominal pain and ataxia, has been observed following exposure to one of two batches of Genta-Equine 100 mg/ml solution for injection for horses, T-001 (expiry date 30 April 2025) or V-001 (expiry date 30 April 2026).
A manufacturing investigation confirmed the presence of histamine in these batches at concentrations high enough to cause adverse reactions. It was therefore concluded that histamine contamination of raw material was the most likely cause.
In response to this finding, testing for the presence of histamine in raw material will be introduced into the manufacturing process for all future batches of Genta-Equine. Furthermore, a recall of the batches T-001 and V-001 has been initiated in Belgium.
Have you observed an adverse event in an animal following exposure to Genta-Equine?
The FAMHP asks that you report any suspected adverse reaction via www.notifieruneffetindesirable-animaux.be or by e-mail: adversedrugreactions_vet@fagg-afmps.be.