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

 

The post MHRA Class 4 Medicines Defect Information: Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension (Sandoz Limited) appeared first on PSNC Website.