Osteomel Once Weekly 70 mg tablets – PA0126/148/002 –10 batches

We wish to advise you that ten batches of Osteomel Once Weekly 70 mg tablets, PA0126/148/002, are being recalled with immediate effect.

This recall is going to pharmacy level.

The reason for the recall is due to out of specification results for the parameter disintegration identified in a number of batches.

Actions to be taken

Information for pharmacists:

Pharmacists are requested to carry out the following actions:

 1. Immediately quarantine any units of the above-listed batches which you have in your possession or are returned to you.  For hospital pharmacists, this includes stock at ward or clinic level. Please make relevant staff at your facility aware of the contents of this recall notification. 
2. Complete the customer return form provided with the recall letter and return it via email to Clonmel Healthcare Ltd.  
3. Return impacted stock to Clonmel Healthcare Ltd. by Friday 16th March 2024. 
4. If you have supplied any other pharmacy, clinic, or healthcare facility with units from the above-listed batches, immediately forward a copy of the recall letter to them, requesting that they quarantine and return any units of the impacted batches to you.

Un-affected stock is available to order at this time from wholesalers.

Information for patients:
No action is required at patient level; however, if you have any concerns, please contact your pharmacist. 

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