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Amoxicillin 500 mg/ 5 ml susp. powder alert

PIL and SmPC listing error

July 21st 2021

Tagged: MHRA alert

By MHRA

Brown & Burk UK Limited has advised of an error in the PIL and SmPC in three batches of amoxicillin 500 mg/ 5 ml powder for oral suspension.

The error relates to the excipient sodium benzoate: the correct and actual quantity of sodium benzoate is 3.75mg/5ml but the PIL reads 7.5mg/5ml and the SmPC 15mg/5ml (1.5mg/ml).

Batch numberExpiry datePack sizeFirst distributed
ASDBV0001Nov. 2022100ml (When reconstituted)14 June 2021
ASDBV0002Nov. 2022100ml (When reconstituted)not yet distributed
ASDBV0003Nov. 2022100ml (When reconstituted)not yet distributed

There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled.

For more information, medical information queries please email: pv@bbukltd.com

For stock enquiries please email: customercare@bbukltd.com