Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sandoz Limited has informed MHRA that the following Co-amoxiclav powder for oral suspension products (amoxicillin trihydrate, potassium clavulanate) are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in Dec 2008 in error. The affected products are:
- Co-amoxiclav 125/31.25mg/5ml powder for oral suspension
- Co-amoxiclav 125/31.25mg/5ml powder for oral suspension (ALMUS LIVERY)
- Co-amoxiclav 250/62.5mg/5ml powder for oral suspension
- Co-amoxiclav 250/62.5mg/5ml powder for oral suspension (ALMUS LIVERY)
For details of the affected batch numbers, please refer to the website in MHRA.
All batches supplied since Dec 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 suspension is equivalent to less than 1% of the maximum daily intake recommended by the World Health Organisation.
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 Jul 2023 all batches manufactured will contain the correct carton artwork.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-co-amoxiclav-125-slash-31-dot-25mg-slash-5ml-250-slash-62-dot-5mg-slash-5ml-powder-for-oral-suspension-el-23-a-slash-14
In Hong Kong, Amoksiklav Oral Suspension (HK-41947), Curam Powder For Oral Susp 156.25mg/5ml (HK-43478) and Curam Powder For Oral Susp 312.5mg/5ml (HK-43479) are Sandoz products containing amoxicillin trihydrate and potassium clavulanate. All products are registered by Novartis Pharmaceuticals (HK) Limited (Novartis). They are prescription-only medicines. As confirmed with Novartis, the packaging of the above 3 registered products in Hong Kong do not contain the wording ‘sugar free’.
Ends/Friday, Apr 21, 2023
Issued at HKT 15:00
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