Recall Notice in respect of Paratabs 500 mg Tablets

Notice type: Recall

Date: 27/09/2006


Product name or type:
Paratabs 500mg Tablets (paracetamol)

Authorisation Number:

Active Substance:

Serial Or Batch Number And Expiry Date:
Batch number: 6022  Expiry Date: 02/2008

Authorisation Holder:
MA Holder: Pinewood Laboratories Ltd. [trading as Pinewood Healthcare]

Prescription Required:

Target Audience:
Patients, healthcare professionals and distributors

Problem Or Issue:
The Irish Medicines Board (IMB) is today issuing an urgent notice for patients in Ireland who have been dispensed Paratabs 500mg Tablets (paracetamol) since the 29th August 2006.   

This notice follows the precautionary recall of Paratabs 500mg Tablets by its marketing authorisation [MA] holder, Pinewood Laboratories Ltd. (trading as Pinewood Healthcare), due to the identification of mould contamination in one particular batch.   

The affected batch could not have been bought over the counter in grocery stores or pharmacies. 
It would only have been dispensed by your pharmacist on foot of a prescription from your doctor. 

Blister packs of paracetamol are not affected.   
Paratabs 500mg Tablets are a brand of paracetamol tablets authorised in Ireland for the management of the symptoms of headaches, toothache, common cold, influenza, menstrual pain, musculoskeletal disorders.    

The IMB is requesting all patients who have been dispensed Paratabs 500mg Tablets since the 29th August 2006 to do the following as soon as possible:   

1. Check the label of the paracetamol tablets that have been dispensed to you to determine if they are Paratabs 500mg Tablets.
2.  If they are Paratabs 500mg Tablets or if you are unsure about them, you should not take any more of the tablets but should return them immediately to your pharmacist for further evaluation and advice.
3. You should tell your pharmacist that you are returning your medicine because of this issue.  
4. The pharmacist will be able to dispense alternative paracetamol tablets.   

The IMB is working with Pinewood Laboratories Ltd. to recall the affected batch of Paratabs 500mg Tablets from all patients, pharmacies, hospitals and wholesalers and to inform all physicians, pharmacists and patients of this issue.   The IMB is also continuing to investigate the cause of the contamination with Pinewood Laboratories Ltd.  

Background Information Or Related Documents:
Recall Notice in respect of Paratabs 500 mg Tablets Document

Further Information:
Siobhan Molloy/Avril Collins Weber Shandwick FCC                
Tel: (01) 676 01 68 or (086) 817 50 66 / (086) 396 4368  

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