Reckitt painkiller packs may contain antipsychotics, says MHRA
pharmafile | August 26, 2011 | News story | Manufacturing and Production, Sales and Marketing | MHRA, Nurofen, Seroquel, parallel imports
Consumers in the UK are being warned to double-check packs of Reckitt Benckiser’s painkiller product Nurofen Plus following reports that some may contain an antipsychotic drug.
The MHRA has issued a Class 4 drug alert to pharmacies warning that AstraZeneca’s Seroquel XL 50mg (quetiapine) tablets may be present in some packs in place of Nurofen Plus (ibuprofen plus codeine) tablets.
While the tablets look very different, the agency has been told that two patients consumed Seroquel XL as a result of the mix-up, apparently without adverse effects.
“The large capsule-shaped Seroquel XL 50 mg tablets can be identified by their gold and black packaging,” said the MHRA in a statement.
The affected 32-tablet packs are in batches numbered 13JJ, 57JJ and 49JJ. One affected pack from each of the batches has been found so far, and an investigation into the mix-up is ongoing.
The Class 4 alert notes that the affected Nurofen Plus products contained “only rogue cut-down blisters of Seroquel XL”, which included tablets which have been imported into the UK by two separate companies holding parallel import licenses.
As the two products are made at different locations, the MHRA does not believe that manufacturing errors are to blame.
“We have some information to suggest possible links between these cases”, it said. “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”, added the MHRA.
Phil Taylor
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