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Nurofen Plus Alert PDF Print Email

Consumers are being warned to check packs of Nurofen Plus after it emerged that thousands could mistakenly contain antipsychotic drugs. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert following reports that some batches contained Seroquel XL 50mg instead of Nurofen Plus.


The affected 32-tablet packs are in batches numbered 13JJ, 57JJ and 49JJ.


The Seroquel tablets are larger and have gold and black packaging, compared with the Nurofen Plus tablets which are smaller and have silver and black packaging.

 

Ian Holloway, from the MHRA's defective medicines report centre (DMRC), said: "People should check to see if they have any affected packets of Nurofen Plus. "If you do, return them to the pharmacy where you bought them from. You can also report this to the MHRA's defective medicines report centre on 020 3080 6574." He added: "If you have taken a tablet and you have any questions, speak to your GP."

 

The MHRA said in a statement, "Serious investigations" were under way to establish how the mix-up occurred, especially as Seroquel XL is manufactured by another drug firm, AstraZeneca. It added: "After careful review of the manufacturing system, manufacturing errors by the makers of Nurofen Plus or Seroquel XL are not thought to be part of the cause at this stage."

 

Dr Aomesh Bhatt, a medical director at Reckitt Benckiser, said: "We are taking this matter extremely seriously and we are working closely with the MHRA to investigate fully. Additionally, we are in the process of working to ensure the Nurofen Plus packs are double-checked by pharmacy staff before they are handed to customers."
"We encourage consumers of Nurofen Plus to be vigilant and, while it is very unlikely, should they find they have a suspect pack or if they have
any other concerns, we advise them to speak to the pharmacist where they purchased the product."

 

 

People with affected packets should return them to their pharmacy; packs from the three batches have been found across the UK.

 

Seroquel XL is a prescription-only anti-psychotic drug used to treat several disorders including schizophrenia, mania and bipolar depression.

 

Nurofen Plus is for pain relief and contains codeine and ibuprofen and is available only behind the counter in pharmacies.

There have been three reports of affected packs. Two people are believed to have taken Seroquel by mistake, but are not thought to have experienced any ill-effects.

 

In a statement, Reckitt Benckiser which makes Nurofen Plus, said the three cases so far been identified had all been in south London.

 

The Full text of the MHRA warning follows below.

 

 

DRUG ALERT

25 August 2011 EL (11)A/21 Our ref:  MDR 21-08/11

Reckitt Benckiser (UK) Ltd

Nurofen Plus tablets

PL 00327/0082 and PL 00063/0376

 

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.

Yours faithfully
Ian Holloway
MHRA DMRC Manager