Ketofall 0.25 mg/ml eye drops, solution in single-dose container – PA1815/002/001 – Three batches
We wish to advise you that three batches of Ketofall 0.25 mg/ml eye drops, solution in single-dose container, PA1815/002/001 are being recalled with immediate effect. This is a prescription medicine.
This recall is going to pharmacy level.
Wholesalers and pharmacists can download a copy of the relevant recall letter below.
As the recall is to pharmacy level, patients are not required to take any actions.
Problem or issue
The reason for the recall is due to a deviation in the manufacturing process where filters were reused in the manufacturing of the above product.
Product information
- Authorisation holder
- Pharma Stulln GmbH
- Authorisation number
- PA1815/002/001
- Serial or batch number and expiry date
-
21M066, expiry 30.11.2023
22C035, expiry 29.02.2024
23A028, expiry 31.01.2025
- Human or veterinary medicine
- Human
- Target audience
- Pharmacists and Wholesalers
- Recall level
- Pharmacy level
Actions to be taken
Information for pharmacists
Pharmacists are requested to carry out the following actions:
1. Please check your current inventory and immediately quarantine any units of the above batches within your pharmacy. For hospital pharmacies, this includes units at wards, clinics and any other relevant locations in the hospital.
2. If you have supplied units from the batches above to any other pharmacy, clinic or other such establishments, please forward a copy of the recall letter to them and request they quarantine and return any unused units to you.
3. Please contact your wholesaler to request an uplift of the affected stock
Unaffected stock of this product is available to order through your wholesaler.
Information for wholesalers
Wholesalers are requested to carry out the following actions
1. Immediately identify and quarantine any units of the above batches which you have in your possession or are returned to you.
2. Identify whether you have supplied units from these batches to any other wholesaler(s) If you have done so, please forward a copy of the recall letter to those wholesalers, requesting that they immediately quarantine and return any unsold quantities of the batches to you.
3. Return all quarantined and returned units to United Drug.
Unaffected stock of this product is available to order.
Information for patients
If you are using this product and have any queries, please contact your pharmacist.