Zaditen 0.25 mg/ml, eye drops, solution, PA1107/010/001, Recall, One batch
15/07/2025
Medicines for human use
Recall
We wish to advise you that one batch of Zaditen 0.25 mg/ml, eye drops, solution is being recalled as a precautionary measure with immediate effect.
This recall is going to pharmacy level.
The reason for the precautionary recall is a potential lack of assurance regarding the sterility of units from the batch, following the occurrence of an environmental microbial contamination incident at the manufacturing site.
The recall letters, dated 11th of July 2025, can be downloaded in the Documents section at the bottom of this webpage.
Product information
- Product name
- Zaditen 0.25 mg/ml eye drops solution
- Authorisation holder
- Théa Pharma Ltd.
- Authorisation number
-
PA1107/010/001
- Serial or batch number and expiry date
- Batch Number: 4V64, Expiry Date: 09 2026
- Human or veterinary medicine
- Human Medicine
- Target audience
- Wholesalers and Pharmacies
- Recall level
- Pharmacy level
Actions to be taken
Information for Pharmacies:
Pharmacists are requested to please perform the following actions:
- Immediately quarantine any units from batch no. 4V64 which you have in your pharmacy. For hospital pharmacies, this includes stock on wards, in clinics and at any other relevant locations within your hospital.
- If you have supplied units from the batch to any other pharmacy, clinic or other such healthcare establishment, forward a copy of the recall letter to them, requesting that they immediately quarantine and return any unused units to you.
- Contact your supplier to arrange the return of quarantined stock.
Information for Patients and Public:
No action is required at user level. If you have this medication in your possession and have any queries, please contact your pharmacist.