IMB COMMUNICATIONS ON NUROFEN PLUS ALERT
August 27, 2011
PSI ADVISES PHARMACISTS TO REMAIN VIGILANT AND ASSIST PATIENTS AFTER IMB ISSUE URGENT ALERT IN RELATION TO NUROFEN PLUS
PLEASE ALSO CHECK IMB WEBSITE www.imb.ie FOR FURTHER UPDATES
SATURDAY 27 AUGUST 14.30: The Irish Medicines Board (IMB) has this afternoon requested the PSI to send the following clarification message to all pharmacists and pharmacies in relation to the Nurofen Plus Tablets issue:
The recall action initiated yesterday (Friday, August 26th 2011) relates to packs of Nurofen Plus at wholesale level only.In relation to packs at pharmacy level, once Nurofen Plus packs in a pharmacy have been checked and confirmed as being unaffected, those unaffected packs may be supplied and they do not need to remain in quarantine.The IMB is continuing to investigate and monitor the situation and will communicate further in the event of new developments. Please note that other Nurofen products are not affected by this issue.
FRIDAY 26 AUGUST 20.30: IMB ALERT TO PHARMACISTS REGARDING NUROFEN PLUS TABLETS:
Please see below an urgent communication from the Irish Medicines Board (IMB) which they have requested the PSI to disseminate to pharmacists, asking for an immediate quarantining and checking of all packs of Nurofen Plus tablets.
The PSI requests that pharmacists are vigilant in relation to this matter and remain alert for any further updates or advice from the IMB.
As stated in the IMB communication, sabotage of the affected product (Nurofen Plus) is suspected and this will raise concerns among patients and the public about the integrity of their medicines and they will seek advice, information and reassurance as necessary from pharmacists and pharmacies.
Contact details are provided for the IMB in the communication below should any rogue blister packs or rogue patient information leaflets be found.
Pharmacists should also report any such findings or serious concerns to the PSI at info@thepsi.ie; this email will be continually monitored over the weekend.
The PSI greatly appreciates the assistance and co-operation of pharmacists and pharmacy staff with this issue.
Communication from the IMB:
Dear Pharmacist,
The Irish Medicines Board (IMB) has asked the PSI to issue the following alert to you:
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 and 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.
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 strips. 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 087-0249808. (For information, the IMB’s main telephone number is 01-6764976.)
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 confirming 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 IMB’s Website (www.imb.ie).
Yours sincerely,
Kevin O'Donnell, PhD,
Market Compliance Manager,
Irish Medicines Board | Bord Leigheasra na hEireann
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.imb.ie
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