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Batch Alert for UK: All Nurofen Plus recalled due to suspected sabotage

By Phenoxide, Aug 25, 2011 | Updated: Aug 26, 2011 | | |
Rating:
4.66667/5,
  1. Phenoxide
    26th August Update: All batches of Nurofen Plus in the UK have now been recalled. Please see the article from The Telegraph below for further details.

    Alert over Nurofen Plus drug mix-up

    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert following reports that some batches of Nurofen Plus contained Seroquel XL [quetiapine] 50mg instead.

    The affected 32-tablet packs are in batches numbered 13JJ, 57JJ and 49JJ. People with affected packets should return them to their pharmacy.

    The mix-up is still under investigation, and 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.

    Each of the affected batches contains between 4,000 and 7,500 packs - around half a million in total. But not all the packs are affected.

    'Serious investigations'

    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. Nurofen Plus is stocked behind the counter in chemists, so people cannot simply pick it up.

    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 DMRC on 020 3080 6574." He added: "If you have taken a tablet and you have any questions, speak to your GP."

    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. And it said "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, medical director for Nurofen Plus, 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."

    BBC News
    25th August 2011
    http://www.bbc.co.uk/news/health-14666291

Comments

  1. Phenoxide
    Re: Batch Alert for UK: Nurofen Plus may contain antipsychotic quetiapine

    Below is the MHRA announcement referred to in the BBC article both in text format and attached as a PDF document:

    DRUG ALERT - CLASS 4 CAUTION IN USE
    (Caution in use, Notification to pharmacy level)
    MHRA Ref: MDR 21-08/11

    Dear Healthcare Professional,

    Nurofen Plus Tablets containing rogue Seroquel XL 50mg tablets (PL 00327/0082 and PL 00063/0376)

    Column 1 Column 2 Column 3 Column 4 Column 5
    Pack size​
    Batch​
    Expiry Date​
    Product License (PL) #​
    First Distributed​
    32 Tablets[/CENTER]
    13JJ​
    03/2014 (March 2014)​
    00327/0082​
    30th April 2011​
    32 Tablets[/CENTER]
    57JJ​
    05/2014 (May 2014)​
    00063/0376​
    21 June 2011​
    32 Tablets[/CENTER]
    49JJ​
    05/2014 (May 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

    MHRA Alert Statement
    MDR 21-08/11
    25th August 2011
    Link
  2. Moving Pictures
    Re: Batch Alert for UK: Nurofen Plus may contain antipsychotic quetiapine

    Fuck, this could be major for codeine CWE users. Imagine them using like 50 or 100 tablets thinking it's codeine when it's really quetiapine!? From a quickie google search, I found that quetiapine is moderately soluble in water. I don't know to what ratio but this could be a serious disaster for anyone doing a CWE on them. Taking one or two Seroquels isn't going to do any damage but taking 50 or more? Woah...
  3. timkanu
    Re: Batch Alert for UK: Nurofen Plus may contain antipsychotic quetiapine


    Hopefully the average CWEer would notice. Still a risk though.

    I'm more worried about the middle aged house wife's that take hand fulls of nurofen+ a day without even using CWE. They probalby would not even notice the differnce in blister pack or tablet shape. They are not exactly known for care or harm reduction. They mindlessly eat grams of nurofen a day without any care for them selfs. So I put little faith in them even noticing or even if they do, they probably just will think its new packaging.
  4. jon-q
    Re: Batch Alert for UK: Nurofen Plus may contain antipsychotic quetiapine

    At first glance i’d be tempted to say doing a CWE with Seroquel XL tablets would cause a few obvious problems, Seroquel XL is a prolonged release formulation of Quetiapine (Quetiapine fumarate) so it should be pretty obvious to the person doing a Cold Water Extraction that something is amiss.

    However as these tablets are being called “Rouge” it could be that the prolonged release formulation isn’t present.

    Good post Phenoxide.
    .
  5. Phenoxide
    Re: Batch Alert for UK: Nurofen Plus may contain antipsychotic quetiapine

    Nurofen Plus recalled amid sabotage fears

    The makers of Nurofen Plus recalled the tablets tonight and confirmed sabotage was suspected in packets of the painkillers.

    Five reported cases of other manufacturers' medicines were discovered in boxes of Nurofen Plus with a spokesman for manufacturer Reckitt Benckiser (UK) Ltd saying: "Sabotage is suspected and we are working with the police on a formal investigation to find the person or persons responsible. Distribution of Nurofen Plus has been halted at this time."

    [IMGR="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=22150&stc=1&d=1314390036[/IMGR]Dr Aomesh Bhatt, Medical Director for Nurofen Plus, added: "We are taking this matter extremely seriously and have decided to recall all packs of Nurofen Plus as the most prudent course of action in the current circumstances. We're asking consumers to return any packs of Nurofen Plus to a pharmacy. No other Nurofen products are affected or being recalled."

    Investigators began trying to establish how some packs of Nurofen Plus came to contain strips of a potentially harmful anti-psychotic drug after yesterday's safety alert. Consumers were warned to check their supplies after the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning that some packs contained Seroquel XL 50mg.

    Three packs of Nurofen Plus were found to contain blister packs of the anti-psychotic medicine. They were bought in Victoria, Bromley and Beckenham, south London. In each pack, the end two capsules of Seroquel XL had been cut off.

    But today, two more packets were found. One contained Seroquel XL 50mg tablets and the other contained the Pfizer product Neurontin 100mg capsules.

    The Reckitt Benckiser spokesman added: "The safety of our consumers is paramount. Even though there have been no serious health consequences to any consumer, we will not take any risk regarding the quality or safety of our products.

    "This decision has been taken in full consultation with the Medicines and Healthcare products Regulatory Agency as a precautionary measure. Consumers are advised to return any packs of Nurofen Plus to any pharmacy where a refund will be provided. Pharmacists are advised to return stock to their wholesaler from where it will be collected."

    Ian Holloway, of the MHRA's Defective Medicines Report Centre (DMRC), said: "People should check to see if they have any packets of Nurofen Plus.

    "If you do, return them to your nearest pharmacy."

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

    People who accidentally take the drug may experience sleepiness and are advised not to drive or operate any tools or machinery until they know how the tablets have affected them. Professor David Nutt, head of the department of neuropsychopharmacology and molecular imaging at Imperial College, said: "The effect of taking Seroquel entirely depends on the dose.

    "The only likely impact of a single ingestion would be sedation, but in people taking antihistamines and other sedatives the added effects could be quite extreme."

    The Telegraph (UK)
    26th August 2011
    http://www.telegraph.co.uk/health/healthnews/8726297/Neurofen-Plus-recalled-amid-sabotage-fears.html

    _________

  6. DriftAway
    Of all the OTC codeine products in the world of course I would happen order Nurofen Plus 32 tablets...aw well I guess we'll see when they get here...agh!
    Thank you so much for this! I could have seriously been hurt due to this mix up.
  7. C.D.rose
    So, if I get this right, then there are different blisters inside Nurofen plus packages, right? I.e. you open the box and on the blister it says Seroquel, or Neurontin? In that case the risk is probably primarily with old people or people who suffer from cognitive deficits. It would have been much worse if there were Seroquel tablets sealed in Nurofen Plus blisters, but still this is quite something.

    Thanks for posting!
  8. Aberdonian
    i think most peole would notice if someone had cut down the strip even if they hadnt noticed thie difference for a start they soon would after reading the back of the strip as for cwe they would notice as they have prob done it 100 times before, still some fucked up people out there doin this kinda shit, who gets their kicks swapping pills around!
  9. kailey_elise
    I dunno, they might not have noticed the cut down strip, and if someone's done a CWE a million times, they might not even LOOK at the back of the package, but just start popping the pills out, kwim?

    But, as they are actual Seroquel tabs, and not Nurofen tabs that have Seroquel in them, hopefully people would notice that they look different.

    I agree; this probably will affect people who DON'T take it very often, older people, people with cognitive difficulties & the 'housewife crowd' that just pops a bunch w/out thinking.

    Regarding who 'gets their kicks' by switching tabs...I dunno, drug addicts? I don't know how Nurofen is packaged, so I don't know if it would be pretty easy to buy a package, slip a different blister pack in & then return it for your money back without the package appearing to be tampered with. In the USA, most of these boxes are sealed with glue; they don't have flaps that can be opened without looking like anyone's ever touched the box, if that makes sense?

    I wonder if this happened in a warehouse situation, or if it's a 'local junkie scam'. The fact that 1 batch was released in April & then the others a few months later, and that they're all in 'south London' (excuse my ignorance, I don't know exactly how big that really is), makes it sound like it might be a 'return scam'...buy a couple packs, swap, return for your money back, repeat at next pharmacy/next town/etc. & now one's unsick for the cost of 1 box...

    So dangerous, though! I mean, if it *IS* a return scam, couldn't you have at least used pills that look NOTHING AT ALL like Nurofen+? So that it would be obvious? Eh, maybe not, if there's a chance the pharmacist is gonna check 'em to make sure you didn't take any before returning the box or something...

    ~Kailey
  10. timkanu
    Apparently it was animal rights protesters. Broke into a ware house and swapped a load of tablets around. (That could be just a clever way to take the blame off the company. Might just have been a total cock up. And instead of admitting blame and probably facing punishment, they blame it on animal rights protesters. lol

    A pack was found in northern Ireland as well.
  11. missparkles
    All pills in the UK are packaged in glued down flaps as KE has said, or they have a serrated flap, that once opened cannot be sealed again?

    I can't understand how animal rights protesters could possibly get into an automated plant, with people all around watching as the pills are put into blisters and then into boxes. Seems highly unlikely that they wouldn't be seen?

    Something not quite right about this story? Not saying it's not true, cos I believe it. I'm saying what if it was a fuck up on behalf of the manufacturer, and they want to shift the blame?


    Sparkles.:vibes:
  12. timkanu
    No, they are just normal boxes with flaps. Not glued down, and you don't have to damage anything to open them.

    Well they were the last time I bought them anyway! :D This goes for Paramol and co-codamol. And every other OTC pain killer I have bought recently.

    Have you seen ones that are glued down miss sparkles? If so, this must be a very new thing.



    I have never come across any OTC tablets that are glued down or sealed in a way that needs breaking to open. They are just normal flaps simply pushed in and out of place.

    Just like this... Nothing glued down and no seal needed to be broken.

    [​IMG]
  13. Micklemouse
    The only people to even speculate it was animal rights protesters were the Daily Mail, who made some spurious link to a vaguely similar case in the states a few years ago & thought was worth trying to drum up a bit of moral outrage on the back of this fiasco. This theory was met with a roll of the eyes & a FFS from all involved.
  14. timkanu

    Oh I didn't realise it was from the dailymail.

    Well its totally not true then. Anything you read in the dailyfail is fabricated to cause mass outrage.
  15. C.D.rose
    Can you actually return pharmaceutical products and get a refund? I'm pretty sure that, at least here where I am at, you can't, and particularly not when it's about drugs that needed a prescription. The reason for that being that it's not you who pays for it, but public health insurance, so it would be the insurance that would get the refund. (Or is codeine OTC in the UK?) Also, even if you can return a medication, I am pretty sure any pharmacist would take a very close look at what's inside.

    No way, in my opinion, that this is a "return scam".
  16. Aberdonian
    drugs cant be returned to a shop or pharmacy in the uk they are destroyed unused or not
  17. Aberdonian
    and yeah codeine and dihydrocodeine are otc here but have paracetamol,ibuprofen or aspirin in them
  18. Phenoxide
    You'd be entitled to recoup your prescription fees I should think. Presumably GPs and pharmacists will form some arrangement that means a suitable replacement medication could be dispensed too. It'd be ridiculous to recall prescription medications and expect people to go without.

    I imagine some pharmacists will check what's in the packaging, let the customer know if there's a problem with it and if there isn't give them the option of taking it away again. Not strictly speaking what they're supposed to do in the case of a product recall but perhaps common sense. The recall is more to protect the company image and stock value than it is to save lives.

    The product in question (Nurofen Plus) is available without prescription but is generally kept below the counter due to its abuse potential.
  19. Aberdonian
    nurofen plus and paramol etc are all otc like j collis brownes mixture which has 20mg morphine in it , and there are no prescription fees now anyway all prescriptions are free
  20. Aberdonian
    free in scotland anyhow
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