Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14

Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.

MDR Number: MDR 230-03/23

Company name: Sandoz Limited

Product description: Co-amoxiclav 125/31.25mg/5ml powder for oral suspension, PL 04416/0514

SNOMED Code: 6032711000001109

Details of the affected batch:

Product description: Co-amoxiclav 125/31.25mg/5ml powder for oral suspension (ALMUS LIVERY), PL 04416/0514

SNOMED Code: 6032711000001109

Product description: Co-amoxiclav 250/62.5mg/5ml powder for oral suspension, PL 04416/0515

SNOMED Code: 6034811000001107

Product description: Co-amoxiclav 250/62.5mg/5ml powder for oral suspension (ALMUS LIVERY), PL 04416/0515

SNOMED Code: 6034811000001107

Active Pharmaceutical Ingredient: amoxicillin trihydrate, potassium clavulanate

 

Brief description of problem:

Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error. All batches supplied since December 2008 have contained a very small quantity of sugar originating from the flavouring. The contained sugars are dextrose and maltodextrin, which are both composed of glucose. However, for a small cohort of patients the product may not be suitable. The maximum daily intake of sugar from Co-Amoxiclav powder for oral solution is equivalent to less than 1% of the maximum daily intake recommended by the World Health Organisation (WHO). The total amount of sugar at the maximum daily doses equates to 204.3 mg in children, 127.8 mg in adults, based on dosing recommendations as per the Summary of Product Characteristics (SmPC).

SmPC: Co-amoxiclav 125/31.25mg/5ml powder for oral suspension, PL 04416/0514 https://mhraproducts4853.blob.core.windows.net/docs/e3c93505e2240f10ef3e81a1a2953a59a26d7b2e

SmPC: Co-amoxiclav 250/62.5mg/5ml powder for oral suspension, PL 04416/0515 https://mhraproducts4853.blob.core.windows.net/docs/593e8aa9baa0bbe9082c8e54eced1cbd3ec54587

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue, and the affected batches are not being recalled. Healthcare professionals are advised to inform patients about the error when dispensing subsequent batches or in discussion with patients who may have concerns related to sugar intake or glucose control, where appropriate.

Healthcare professionals should be aware that due to the continuity of supply, a small number of extra batches of each product, which contain small amounts of sugars, will be released to the market, even though the carton will indicate that these products are ‘sugar free’. Sandoz have confirmed that after July 2023 all batches manufactured will contain the correct carton artwork.

Advice to Patients:

This notification relates to the fact that the products noted above contain a small quantity of sugar while the carton states ‘sugar free’. Patients do not need to take any action as the medicine itself is not affected. Any suspected adverse reactions should be reported via the MHRA Yellow Card Scheme.

Company contacts for further information:

For more information, medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101

For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607

To access the full recall:

Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14