Class 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18
July 20, 2021
Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoate
PL Number
PL 25298/0248
MDR Number
MDR 232-06/21
Company Name
Brown & Burk UK Limited
Product description
Amoxicillin 500 mg/ 5 ml Powder for oral suspension
| 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.
Brief description of the problem
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).
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.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
Further Information
For more information, medical information queries please contact:
Email: pv@bbukltd.com
For stock enquiries please contact:
Email: customercare@bbukltd.com
Tel: 0203 384 7188
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice.
NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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Published 19 July 2021
