Wednesday, August 31, 2011

500,000 drugs recalled after anti-psychotics are found in packs on Nurofen Plus

PEOPLE have been warned that packs of Nurofen Plus may contain a powerful drug used to treat mental patients.

Regulators yesterday said blister packs of Seroquel XL 50mg - an anti-psychotic - had been found in three batches of 32-packs of the painkillers.

Each batch contains between 4000 and 7500 packs, amounting to around 500,000 tablets. But not all packets were affected.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued the safety alert.

The switch is believed to have happened at a wholesaler's as the drugs are made by different firms.

One line of inquiry is that the anti-psychotic drugs were deliberately placed in Nurofen Plus packs by animal rights activists.

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

Nurofen Plus - for pain relief - contains codeine.

The large capsules of Seroquel XL 50mg tablets have gold and black packaging, while the Nurofen Plus tablets are smaller and have silver and black packaging.

Ian Holloway, from the MHRA's defective medicines report centre, 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. You can also report this to us on 020 3080 6574.

"If you have taken a tablet and you have any questions, speak to your GP."

Reckitt Benckiser, who make Nurofen Plus, said there had been three cases identified so far, which were confined to south London.

They said "serious investigations" are under way to find out how the mix-up happened, especially as Seroquel is made by rivals AstraZeneca.

Reckitt Benckiser added: "After a 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. We are taking this matter very seriously and are working closely with the MHRA and pharmacies.

"The MHRA are investigating the issue and have considerable law enforcement powers.

"Nurofen Plus is a pharmacyonly medicine, which means it is behind the pharmacy counter.

"It is not available for self-selection from the shop floor. Therefore, pharmacists are able to check packs and greatly reduce the likelihood of affected packs being sold."

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.

"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 who accidentally take Seroquel may experience sleepiness and are advised not to drive or operate any tools or machinery until they know how the tablets have affected them.

Other side effects include dizziness and headache.

A statement from Astra-Zeneca said: "Patient safety is the primary concern of AstraZeneca and the company are taking this issue seriously.

"AstraZeneca are collaborating with the MHRA and Reckitt Benckiser to investigate the root cause."

Recall Batch Numbers Batch Number 13JJ Expiry Date 03/2014 Product Licence No 00327 / 0082 Batch Number 57JJ Expiry Date 05/2014 Product Licence No 00063 / 0376 Batch Number 49JJ Expiry Date 05/2014 Product Licence No 00063 / 0376


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