DRUG ALERTCLASS 4 CAUTION IN USE
Notification to pharmacy level
|25 August 2011||EL (11)A/21||Our ref: MDR 21-08/11|
Dear Healthcare Professional,
Reckitt Benckiser (UK) Ltd
Nurofen Plus tablets
|Nurofen Plus Tablets containing rogue Seroquel XL 50mg tablets||PL 00327/0082 and PL 00063/0376|
|Pack size||Batch number||Expiry date||PL||First distributed|
|32 Tablets||13JJ||03/2014||00327/0082||30 April 2011|
|32 Tablets||57JJ||05/2014||00063/0376||21 June 2011|
|32 Tablets||49JJ||05/2014||00063/0376||1 July 2011|
Reckitt Benckiser (UK) Ltd has received three reports of rogue Seroquel XL 50mg tablets in cartons of three different batches of Nurofen Plus tablets. We understand cartons of Nurofen Plus tablets contained only rogue cut-down blisters of Seroquel XL tablets and no Nurofen Plus tablets were present. The rogue Seroquel XL tablet cut-down blisters included parallel imported tablets (from two different PLPI companies) and originator product.
The three batch numbers in the table above are the numbers on the Nurofen Plus tablet cartons which can be used to identify the at-risk stock.
Seroquel XL tablets are made by a different company (AstraZeneca) at a different site. Manufacturing errors by Reckitt Benckiser and AstraZeneca are not considered to be part of the cause at this stage.
We have some information to suggest possible links between these cases. It is possible that these problems are linked to product consolidation and/or erroneous examination of returns. Work is ongoing to obtain more information but the full facts may never be fully established.
Recipients are requested to remain vigilant about this issue and requested to report any further cases or additional concerns promptly to DMRC on 020 3080 6574.
There are marked visual differences between the two products but we have been informed that two patients took Seroquel XL instead of Nurofen Plus tablets.
For medical information enquiries related to Seroquel XL Tablets please contact AstraZeneca Ltd medical information department on 0800 783 0033. For medical information enquiries related to Nurofen Plus Tablets please contact Reckitt Benckiser (UK) Ltd medical information department on 0500 455 456.
Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this information to General Practitioners, Community Pharmacists and relevant clinics by copy of this letter.
MHRA DMRC Manager
Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland P
rison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)