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Amantadine hydrochloride Renata, Amantadin STADA® Tabletten (EMP) and MANTADIX® (EMP) - Batch recall

16/06/2026
Medicines for animal use Recall

 

We wish to advise you that the batches listed below of Amantadine hydrochloride Renata 100 mg Capsules, hard, PA 22865/005/001, Amantadin STADA® 100 mg Tabletten (EMP) and MANTADIX® 100 mg capsule (EMP) are being recalled with immediate effect.

This recall is going to veterinarian level onlyThe reason for the recall is that Amantadine products are for human use and are prohibited as a veterinary treatment, in accordance with Regulation (EU) 2022/1255.

The recall letter can be found in the Documents section at the bottom of this page.

Product information

Product name
See Reference section for table of recalled products
Manufacturer or supplier
DUGGAN VETERINARY SUPPLIES LTD
Human or veterinary medicine
Veterinary Medicine
Target audience
Veterinary clinics

Actions to be taken

Information for Veterinarians

Veterinarians are requested to please perform the following actions:

  1. Check your current inventory to establish if you have any units of the listed batches and immediately quarantine any units of these batches that you have in your possession. Physically segregate quarantined stock in a secure area away from saleable stock and label it appropriately as recalled stock.
  2. If you have supplied units of these batches to any other Veterinary Practice, forward those customers a copy of the recall letter and the attachments (in the Documents section at the bottom of this page), requesting that they quarantine and return any unsold quantities to you.
  3. Complete the Product Return Form (attached to the recall letter) indicating the number of units quarantined at your facility and return the form to Duggan Veterinary Supplies Limited. Duggan Veterinary Supplies Limited will arrange the uplift of quarantined stock once the completed form is received.
  4. Complete the Product Return Instruction Form (attached to the recall letter) and include with the quarantined stock.

Reference

Product nameMarketing Authorisation No.Batch No.Expiry
Amantadine hydrochloride Renata 100 mg Capsules, hardPA 22865/005/001R1224006111/2028
Amantadine hydrochloride Renata 100 mg Capsules, hardPA 22865/005/001R1223001106/2026
Amantadin STADA® 100 mg TablettenUnauthorised (Exempt Medicinal Product)42902A06.2029
MANTADIX® 100 mg capsuleUnauthorised (Exempt Medicinal Product)M010812-2026

 

Documents

Opens in new window Amantadine hydrochloride Renata,Amantadin STADA® and MANTADIX®- Veterinary recall letter-16June2026-pdf PDF : 242KB | 16/06/2026