Quality & complianceOfficial

MHRA flags Sandoz co-amoxiclav suspension SmPC dosing table error implying roughly double dose

🇬🇧 MHRA alerts · Thu 05 Nov 2026

A Class 4 defect notice says the weight-based dosing table in Sandoz's co-amoxiclav 250/62.5 mg/5 ml SmPC is wrong, and the document has been withdrawn from MHRA and eMC websites.

The Medicines and Healthcare products Regulatory Agency (MHRA) published Class 4 Medicines Defect Notification EL(26)A/46 on 5 November 2026. Sandoz Limited, the marketing authorisation holder, told the agency 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 (PL 04416/0515).

The notice says the table in Section 4.2, which sets out weight-adjusted dosing, specified a volume of oral suspension that would deliver approximately twice the intended recommended dose. It says the quality of the powder for oral suspension itself is not affected, and that all batches are covered because the problem lies in the SmPC rather than in a particular lot.

The defective SmPC has been taken down from the MHRA products website and the electronic medicines compendium (eMC). The corrected SmPC will be posted once Sandoz has been granted a variation to its marketing authorisation. In the meantime, the agency tells healthcare professionals not to use the Sandoz SmPC to calculate weight-adjusted doses and points them to corrected dosing information supplied by Sandoz in Annex 1 of the notice.

The MHRA warns that following the faulty table could lead to overdose and raise the likelihood of known dose-related effects. These include gastrointestinal symptoms such as antibiotic-associated diarrhoea, nausea, vomiting and abdominal pain, dehydration with fluid and electrolyte disturbance, and hypersensitivity and other adverse reactions. It also notes that amoxicillin crystalluria, including acute renal injury or failure, has been reported but is described as very rare and mainly linked to parenteral therapy.

For patients, the advice is to carry on taking the medicine as prescribed. Anyone who thinks they have taken or given the higher dose and has symptoms such as diarrhoea, nausea, vomiting or abdominal pain should seek immediate medical advice, and those with questions can ask their pharmacy or treating clinicians. For context, Class 4 is the lowest tier of the MHRA's defect classification and is generally used for issues that pose little or no risk to patients.

What it means for your team

  • Regulatory affairs teams at Sandoz and other MAHs should note that an SmPC error can trigger a defect notification and temporary withdrawal of the document from public databases, pending a variation.
  • Pharmacovigilance teams should watch for adverse reaction reports linked to possible co-amoxiclav overdose, especially gastrointestinal, dehydration and hypersensitivity events in patients dosed by weight.
  • Quality and medical information teams should ensure that prescribers and pharmacists are directed to the corrected dosing in Annex 1 rather than the withdrawn SmPC.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

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