MHRA Class 4 Medicines Defect Notification: Co-Amoxiclav powder for oral suspension 250/62.5 mg/5ml (Sandoz Limited)

MHRA Class 4 Medicines Defect Notification: Co-Amoxiclav powder for oral suspension 250/62.5 mg/5ml (Sandoz Limited)

Drug alert number: EL(26)A/46

Date issued: 05 November 2026

Sandoz Limited have informed the MHRA of errors in the dosing table in the Summary of Product Characteristics (SmPC) for Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension.

DMRC reference number: DMRC- 41234128

Marketing Authorisation Holder: Sandoz Limited

Medicine Details

Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL

PL: 04416/0515

Active ingredient: amoxicillin trihydrate, potassium clavulanate

SNOMED code: 43647311000001107

GTIN: 05015915880116

Affected Lot Batch Numbers

All batches are currently impacted.

Background

Sandoz Limited have informed the MHRA of errors in the dosing table in the Summary of Product Characteristics (SmPC) for Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension. The quality of the powder for oral suspension is not impacted by this defect.

The dosing table in Section 4.2 of the defective SmPC, that provides the instruction for weight adjusted dosing, is incorrect and should not be used. The defective SmPC has been removed from the MHRA products and electronic medicines compendium (eMC) websites.

The defective SmPC dosing table instructed an amount of oral suspension that provided approximately twice the intended, recommended dose.

Advice for Healthcare Professionals

The corrected dosing information provided by Sandoz Limited is included in Annex 1.

Do not use the Sandoz SmPC for calculating the dosing for weight adjusted administration of this medicine. The defective SmPC has been removed from the MHRA products and electronic medicines compendium (eMC) websites; these will be available once Sandoz has received a granted variation to their market authorisation for the new SmPC.

Based on the defective SmPC instruction, there is a potential for an overdose, this may increase the likelihood of known dose-related adverse effects, such as:

• Increased risk of gastrointestinal symptoms antibiotic-associated diarrhoea, nausea, vomiting and abdominal pain and dehydration, of fluid and electrolyte balance
• Increased risk of hypersensitivity and other adverse reactions
• Amoxicillin crystalluria, including acute renal injury/renal failure, has been reported but is described as very rare and predominantly associated with parenteral therapy.

View the full alert here.

Advice for Healthcare Professionals to Provide to Patients:

Patients should continue to take this medication as prescribed. If you believe you have taken or administered the higher dose of co-amoxiclav and are currently experiencing any side effects such as diarrhoea, nausea, vomiting or abdominal pain then please seek immediate medical advice.

If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals involved in your treatment.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the  MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries and information on this product, please email mi.uk@sandoz.com or telephone 01276 698101.