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www.fdanews.com/articles/88603-mhra-issues-class-2-drug-alert-for-10-mg-aricept

MHRA ISSUES CLASS 2 DRUG ALERT FOR 10-MG ARICEPT

November 3, 2006

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has posted a notice on its website of a Class 2 drug alert because Lexon is recalling a batch of Aricept (donepezil hydrochloride). The 10-mg tablets are being recalled because the blister strips from one packing run are incorrectly labeled as Aricept 5-mg tablets. The packing run number is only printed on the carton and is not printed on the blisters.

The MHRA said that Lexon has repacked this batch number on several occasions, but only one of the packing runs is faulty. Recipients of the drug are being asked to quarantine all remaining stock with the affected batch number and return it to their supplier. The affected batch is No. 6022703, with an expiration date of March 2009.

Aricept is a once-a-day treatment for mild to moderate dementia related to Alzheimer's disease.

To view the drug alert, go to www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025132&ssTargetNodeId=364.