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Recall notice for Ketofall 0.25 mg/ml eye drops, solution in single-dose container, PA1815/002/001

Notice type: Recall

Date: 08/09/2023

 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 recall is going to pharmacy level.

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. 

Wholesalers can download a copy of the wholesale recall letter.
Pharmacist can download a copy of the pharmacy recall letter.

As the recall is to pharmacy level, patients are not required to take any actions. 
 

Product name or type:
Ketofall 0.25 mg/ml eye drops, solution in single-dose container

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

Authorisation Holder:
Pharma Stulln GmbH

Prescription Required:
Yes

Recall Classification:
Pharmacy level recall

Target Audience:
Pharmacists and Wholesalers

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.

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