Nurofen Plus recall in UK prompts police enquiry

Nurofen Plus pack and blisterThe discovery of powerful central nervous system medications in packs of Reckitt Benckiser's painkiller product Nurofen Plus has prompted a UK police investigation to see if the case involves deliberate sabotage.

Consumers in the UK were warned last week to double-check 32-count packs of pharmacy-only Nurofen Plus (ibuprofen plus codeine tablets) following reports that some may contain blisters housing AstraZeneca's Seroquel XL 50mg (quetiapine tablets) or Pfizer's epilepsy drug Neurontin (gabapentin capsules).

The case has been referred to the Metropolitan Police for further investigation by its Specialist Crime Directorate.

"Sabotage is suspected and we are working with the police on a formal investigation to find the person or persons responsible," a spokesman for Reckitt told the Herald Scotland newspaper, although to date no blackmail or related threat has been made to the company.

The MHRA issued a Class 4 drug alert to pharmacies after five boxes were found with the wrong contents, and the manufacturer announced a consumer-level recall of an estimated 250,000 packs. Four of the cases involved Seroquel XL and occurred in London and Beckenham, while a fifth in Northern Ireland involved Neurontin.

The MHRA said two patients had consumed Seroquel XL as a result of the mix-up, apparently without adverse effects. The Neurontin pack was discovered by a pharmacist.

The Class 4 alert notes that the Seroquel instances involved "rogue cut-down blisters", which included tablets which were imported into the UK by companies holding parallel import licenses, as well as originator product.

As the two products are made at different locations, the MHRA does not believe that manufacturing errors are to blame because the medicines are made at different facilities, but said it was investigating whether the cases relate to consolidation - where left over medicines are returned to pharmacies and wholesalers and repacked - or deliberate tampering.

Regardless of the source of the mix-up, the case raises some serious questions about the security of the pharmaceutical supply chain.

Consolidation is technically illegal in the UK but is thought to be fairly common practice. Meanwhile, repackaging of medicines by parallel traders - which take advantage of the different prices of medicines between EU countries, buying stocks in low-priced markets and selling them at a discount in markets where prices are higher - has long been held up as a potential source of breaches in the pharmaceutical supply chain.

Despite pressure to ban parallel importation of medicines, the European Commission's position has been that the ban would run counter to the principles of free trade in the EU.

The case lends support to the position voiced by many pharmaceutical manufacturers that medicines should be supplied in the same sealed and (ideally) tamper-evident packaging in which they leave the original factory, although it should be noted these measures are less common for over-the-counter and pharmacy-only brands such as Nurofen Plus.

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