On 18 May 2023 ACVM provided communication that:
1. Confirms ACVM will commence a formal reassessment of all anthelmintic ruminal bolus product registrations in New Zealand, and
2. Confirms a decision to prohibit sale and use of the Bionic Plus (ACVM number A01125) and Bionic Plus Hogget (ACVM number A011826) controlled release capsule products during the period of the reassessment. The time required for the reassessment is not yet known but it is a high priority.
On 18 August 2022, Boehringer Ingelheim and Argenta Manufacturing initiated a recall of four batches of Bionic Plus Hogget manufactured by Argenta Manufacturing and distributed by Boehringer Ingelheim in New Zealand. This product remains unavailable.
In November 2022, during the investigation of Bionic Plus Hogget, it was found that some capsules recovered from older sheep treated with Bionic Plus (ACVM Reg. No. A011825) had also shown signs that the product may not be performing as expected.
Boehringer Ingelheim made the decision to voluntarily cease the sale of Bionic Plus (adult) capsules until such time as the investigations with Argenta were completed. Therefore, we anticipate small quantities of Bionic Plus may still be on farm due to the voluntary stop sale. ACVM has now issued the notice detailed
in paragraph 2 above.
The prohibition on use means that any product already on farm must not be administered to sheep until such time as the ACVM updates this notification. Farmers may choose to store product they have already purchased in case the prohibition is lifted after the reassessment or return it to the veterinary clinic where it was purchased (though returns are not required).
Argenta Manufacturing is working to confirm a definitive cause for the altered release of active ingredients for Bionic Plus and Bionic Plus Hogget. We will continue to provide updates as more information becomes available.
If you have any questions in relation to this communication can you please contact Jason Haar in the Wairoa clinic or Phil Ware in the Gisborne clinic
Eastland Veterinary Services