Nurofen Plus recall expanded
pharmafile | August 31, 2011 | News story | Sales and Marketing |Â Â MHRA, Nurofen, recallsÂ
Last week’s recall of Reckitt Benckiser’s painkiller product Nurofen Plus has been expanded after two additional cases emerged where powerful prescription-only medicines were found in packs distributed in the UK.
The new findings have also prompted a police investigation to examine the supply chain in the case, and try to identify the source of the substitution.
The MHRA issued a Class 4 drug alert to pharmacies last week after three reports of AstraZeneca’s Seroquel XL 50mg (quetiapine) tablets being present in packs of Nurofen Plus (ibuprofen plus codeine) tablets distributed in London.
Since then, one additional case involving Seroquel XL substitution has been found in a Nurofen Plus back in Beckenham, while Pfizer’s anti-epilepsy drug Neurontin (gabapentin) capsules have been found in one pack checked by a pharmacy in Northern Ireland.
As a result, the MHRA has now issued a Class 1 drug alert to all UK healthcare professionals and Reckitt Benckiser has ordered a recall of all remaining unexpired stock of Nurofen Plus, in any pack size, and halted distribution of the product. The recall is estimated to involve around 250,000 packs.
The Metropolitan Police and MHRA are examining the incidents amid speculation that the substitution could be a case of deliberate sabotage. Reckitt Benckiser said this was a possibility but that it had not received any threats or blackmail messages.
The MHRA has said it cannot rule out tampering, but noted the mix-up could also have occurred as a result of consolidation, where leftover medicines are returned to pharmacies and wholesalers, repacked and then offered for sale once again.
The Class 4 alert noted 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.
Phil Taylor
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