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 name
Co-amoxiclav 125/31.25mg/5ml powder for oral suspension, PL 04416/0514
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.
Advice for 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.
Further Information
For more information, medical information queries, please contact: [email protected], Telephone: +44 1276 698 101
For stock control queries, please contact: [email protected], Telephone: +44 1276 698607
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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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