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Urgent Information for Pharmacists: Nurofen Plus Tablets, PA 979/34/1 and PPA 1151/126/1 – All Batches : Precautionary Immediate Action Required

Notice type: Advisory

Date: 26/08/2011

  

Product name or type:
Nurofen Plus Tablets - All Batches

Authorisation Number:
PA 979/34/1 and PPA 1151/126/1

Target Audience:
Pharmacist

Problem Or Issue:
Dear Pharmacist, 

The Irish Medicines Board (IMB) wishes to advise you of the following: 

Packs of Nurofen Plus Tablets have been found on the UK market (including Northern Ireland) to contain rogue blister strips of either Seroquel XL 50mg Tablets or Neurontin 100mg Capsules. While there have been no serious health consequences to any consumer in the UK, sabotage of the product is suspected and Reckitt Benckiser UK is working with the UK police on a formal investigation into the issue. 

Distribution of Nurofen Plus has been halted in Ireland and in the UK at this time. 

Situation in Ireland: 

There is no evidence at this time that the Irish market is affected. The impacted Nurofen Plus pack size on the UK market is a 32 pack size and this pack size is not authorised for sale in Ireland. 

This issue only applies to Nurofen Plus Tablets and no other Nurofen product is affected. 

As a precautionary measure, and following discussions with the IMB, Reckitt Benckiser (Ireland) has decided to recall from the wholesale distribution chain in Ireland all unexpired packs of Nurofen Plus Tablets, in all pack sizes and of any batch number. This is so that those packs can be checked for the presence of rogue blister strips and Patient Information Leaflets. 

With regard to packs of Nurofen Plus Tablets at pharmacies in Ireland, pharmacists are hereby requested to immediately quarantine all packs of Nurofen Plus Tablets that are in their pharmacies and to open and check those packs for the presence of any rogue blister strip. Pharmacists should also check that the Patient Information Leaflet in each pack is for Nurofen Plus Tablets and not for another product. 

In the event that any packs are found in pharmacies to contain either a rogue blister strips or a rogue Patient Information Leaflet, the pharmacist should immediately put that pack in a secure place and immediately telephone Kevin O’Donnell at the Irish Medicines Board on 087-9562818. Alternative contacts at the IMB are Breda Gleeson at 087-9703559 and Aoife Farrell at 086-0249808. (For information, the IMB’s main telephone number is 01-6764971.) 

Please do not wait until your inspection of all stock is completed to report any rogue findings to the IMB. 

Please note that the above request to check packs pertains to all packs of Nurofen Plus Tablets (Ibuprofen and Codeine), regardless of whether they are originator Reckitt Benckiser PA packs or Parallel Imported PPA packs. 

If you receive queries from patients about this issue, as a precautionary measure, please advise them to check their packs to make sure that they contain Nurofen Plus blister strips and a Nurofen Plus Patient Information Leaflet. In the event that a patient contacts you to advise that they have identified a different product or a different Patient Information Leaflet within their pack of Nurofen Plus, please ask them to bring their pack to you and please immediately contact the IMB with this information. 

Please note that a letter comfirming the above requests will be sent to you next week by Reckitt Benckiser. 

Information about Medical Information Enquiries: 

For medical information enquiries related to Nurofen Plus Tablets please contact Reckitt Benckiser (Ireland) Ltd medical information department on 01 -6305429 

For medical information enquiries related to Seroquel XL Tablets please contact AstraZeneca Ltd medical information department on 00 44 800 783 0033. 

For medical information enquiries related to Neurontin 100mg Capsules please contact Dr. John Farrell at Pfizer medical information on 086 238 7516. 

The IMB is continuing to investigate and monitor the situation and we (IMB) will communicate with you if new developments arise and further actions are required.

Thank you very much for your assistance with this issue. This alert is also on the website (www.hpra.ie). 

Background Information Or Related Documents:
Urgent Information for Pharmacists: Nurofen Plus Tablets, PA 979/34/1 and PPA 1151/126/1 – All Batches : Precautionary Immediate Action Required Document

Further Information:
Kevin O'Donnell, PhD, 

Market Compliance Manager, 
Health Products Regulatory Authority | An tÚdarás Rialála Táirgi Sláinte
Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2 
Tel: +353 1 6764971 
Fax: +353 1 6767836 
Mobile: +353 87 9562818 
kevin.odonnell@imb.ie 
www.hpra.ie

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