Class 4 Medicines Defect Information: Amoxicillin 500mg/5ml Powder for oral suspension

Class 4 Medicines Defect Information: Amoxicillin 500mg/5ml Powder for oral suspension

July 19, 2021

Class 4 Medicines Defect Information: Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18

MDR Number: MDR 232-06/21

Date issued: 19 July 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information:

Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248)

Brown & Burk UK Limited would like to notify you of an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension, sold and distributed in the UK. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75mg/5ml. On the PIL it is incorrectly reported as 7.5mg/5ml and in the SmPC it is 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

Active Pharmaceutical Ingredient: Amoxicillin trihydrate

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. The batches not yet distributed have been included in this alert to inform HCPs accordingly. These batches were subject to a batch specific variation, assessed by the MHRA and it was considered that the risk associated with the incorrect information was low and therefore no market action considered.

The product information is in the process of being revised to reflect the correct quantity of sodium benzoate and new batches will be only be distributed with the correct information

Further Information

Full Medicines Notification can be viewed here

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

For stock enquiries, please contact: customercare@bbukltd.com or 0203 384 7188

 



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