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