Prulab Pharma Limited is recalling one batch of clopidogrel oral solution 75mg in 5ml [unlicensed medicine].
The affected batch is
|Batch Number||Expiry Date||Pack Size||First Distributed|
|D2207227403B||21 July 2023||150ml||05 September 2022|
The recall is due to a discrepancy with the product labelling that could result in an incorrect volume to be administered to the patient.
The strength of the formulation reflected in the product name on the front label does not align with the quantitative composition of the product, which states “Each 5ml contains 75mg clopidogrel hydrogen sulfate”.
Healthcare teams should quarantine and return any items from this affected batch to the company directly.
Patients and caregivers who have been dispensed with this unlicensed medicine will be contacted by their clinical teams. Patients should not change their dose of oral clopidogrel unless they are told to do so by a healthcare professional.