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

Class 4 Medicines Defect Information:

Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension (Sandoz Limited)

Drug alert number: EL (23)A/14

Date issued: 20 April 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Product name: Co-amoxiclav 125/31.25mg/5ml powder for oral suspension, PL 04416/0514 (Sandoz Limited)

SNOMED Code: 6032711000001109

Batch No Expiry Date Pack Size First Distributed
KN7289 30/04/2023 1 11/06/2020
KN1408 30/04/2023 1 02/07/2020
KN1409 30/04/2023 1 02/07/2020
KN1406 30/04/2023 1 09/07/2020
KN1410 30/04/2023 1 16/07/2020
KS7930 30/06/2023 1 03/09/2020
KS7928 30/06/2023 1 03/09/2020
KS7929 30/06/2023 1 03/09/2020
KS7925 30/06/2023 1 11/09/2020
KX1634 30/09/2023 1 03/12/2020
KZ5913 31/10/2023 1 26/03/2021
KZ5911 31/10/2023 1 26/03/2021
LA6145 30/11/2023 1 08/04/2021
LA6142 31/10/2023 1 18/05/2021
KZ7804 31/10/2023 1 20/05/2021
LG8908 30/04/2024 1 08/07/2021
LJ0774 31/05/2024 1 15/07/2021
LJ0772 30/04/2024 1 15/07/2021
LJ0777 31/05/2024 1 15/07/2021
LJ8598 31/05/2024 1 29/07/2021
LJ8597 31/05/2024 1 30/07/2021
LR5163 30/09/2024 1 21/12/2021
LV2132 30/09/2024 1 18/03/2022
MB7217 28/02/2025 1 23/05/2022
MB3089 28/02/2025 1 23/05/2022
MB7213 28/02/2025 1 23/05/2022
MB9154 28/02/2025 1 27/06/2022
MH3989 30/06/2025 1 20/09/2022
MJ3047 31/08/2025 1 21/10/2022
MN4528 31/10/2025 1 12/01/2023
MN4525 31/10/2025 1 12/01/2023
MP2985 31/10/2025 1 23/01/2023
MP2984 31/10/2025 1 23/01/2023
MS7591 31/12/2025 1 03/03/2023
MS5699 31/12/2025 1 08/03/2023
MS5698 31/12/2025 1 08/03/2023
MP5588 31/10/2025 1 14/03/2023
MT2296 31/12/2025 1 17/03/2023

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

SNOMED Code: 6032711000001109

Batch No Expiry Date Pack Size First Distributed
LL9525 31/05/2024 1 27/08/2021
LM7892 31/05/2024 1 12/11/2021
MB7218 28/02/2025 1 06/05/2022

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

SNOMED Code: 6034811000001107

Batch No Expiry Date Pack Size First Distributed
KN7345 30/04/2023 1 24/06/2020
KN7348 30/04/2023 1 24/06/2020
KN7343 30/04/2023 1 24/06/2020
KN7344 30/04/2023 1 26/06/2020
KN7346 30/04/2023 1 29/06/2020
KN7349 30/04/2023 1 29/06/2020
KN7351 30/04/2023 1 09/07/2020
KN7355 30/04/2023 1 09/07/2020
KN7356 30/04/2023 1 10/07/2020
KN7358 30/04/2023 1 10/07/2020
KN7359 30/04/2023 1 04/08/2020
KU1888 31/07/2023 1 21/10/2020
KV9017 31/08/2023 1 12/11/2020
KV9018 31/08/2023 1 12/11/2020
KV9030 31/08/2023 1 19/11/2020
KV9015 31/08/2023 1 24/11/2020
KZ8872 31/10/2023 1 18/02/2021
KZ8870 31/10/2023 1 18/02/2021
KZ8869 31/10/2023 1 18/02/2021
LB0656 30/11/2023 1 22/02/2021
LA1951 31/10/2023 1 22/02/2021
KZ8863 31/10/2023 1 26/03/2021
LA1953 30/11/2023 1 08/04/2021
LA1954 30/11/2023 1 08/04/2021
KZ8864 31/10/2023 1 15/04/2021
KZ8866 31/10/2023 1 07/05/2021
LH0734 30/04/2024 1 24/06/2021
LH0736 30/04/2024 1 01/07/2021
LJ8596 31/12/2023 1 30/07/2021
LL7416 30/06/2024 1 09/09/2021
LM6701 31/08/2024 1 01/11/2021
LM6702 31/08/2024 1 02/11/2021
LM6705 31/08/2024 1 10/11/2021
LM6706 31/08/2024 1 10/11/2021
LR6835 31/10/2024 1 2/02/2022
LL9622 30/06/2024 1 22/02/2022
LP2509 31/08/2024 1 22/02/2022
MB7827 28/02/2025 1 08/07/2022
MG6831 30/06/2025 1 02/09/2022
MF7424 31/05/2025 1 06/09/2022
MG1126 30/06/2025 1 06/09/2022
MG1127 30/06/2025 1 06/09/2022
MG7519 30/06/2025 1 13/09/2022
MG6832 30/06/2025 1 20/09/2022
MG7521 30/06/2025 1 20/09/2022
MG6833 30/06/2025 1 20/09/2022
MH3996 30/06/2025 1 27/09/2022
MJ7424 31/07/2025 1 28/10/2022
MJ7426 31/07/2025 1 25/11/2022
MJ7425 31/07/2025 1 25/11/2022
MJ8744 31/08/2025 1 25/11/2022
MK2855 31/08/2025 1 25/11/2022
ML7555 30/09/2025 1 25/11/2022
ML7558 30/09/2025 1 30/11/2022
MN0722 31/10/2025 1 22/12/2022
MP2508 31/10/2025 1 19/01/2023
MP4622 31/10/2025 1 19/01/2023
MP7479 31/10/2025 1 19/01/2023
MP1482 31/10/2025 1 19/01/2023
MP2509 31/10/2025 1 09/02/2023
MS1090 31/12/2025 1 03/03/2023
MR6781 31/10/2025 1 03/03/2023

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

SNOMED Code: 6034811000001107

Batch No Expiry Date Pack Size First Distributed
LM6707 31/08/2024 1 27/10/2021
LM7608 31/08/2024 1 08/12/2021
MB7828 28/02/2025 1 08/07/2022
MG9435 30/06/2025 1 20/09/2022

Active Pharmaceutical Ingredient: amoxicillin trihydrate, potassium clavulanate

Brief description of the 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 for 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.

View full alert here.

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

 

Support the call for more funding by recording information about the informal advice you provide to patients over just one day.

Click Here