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 number||Expiry date||Pack size||First distributed|
|ASDBV0001||Nov. 2022||100ml (When reconstituted)||14 June 2021|
|ASDBV0002||Nov. 2022||100ml (When reconstituted)||not yet distributed|
|ASDBV0003||Nov. 2022||100ml (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.
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