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MHRA: Sandoz co-amoxiclav suspension SmPC dosing table error could double weight-based dose

🇬🇧 MHRA alerts · Thu 05 Nov 2026

The MHRA has issued a Class 4 defect notification for Sandoz's 250/62.5 mg/5 mL co-amoxiclav oral suspension after its SmPC dosing table was found to be wrong, with all batches affected.

The Medicines and Healthcare products Regulatory Agency (MHRA) published notification EL(26)A/46 on 5 November 2026. Sandoz Limited told the agency that 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) contains errors.

The table in Section 4.2, which gives weight-adjusted dosing instructions, should not be used. The MHRA says it directed an amount of oral suspension equal to roughly twice the intended recommended dose. The agency states that the quality of the powder itself is not affected, and all batches are listed as impacted.

The defective SmPC has been taken off the MHRA products site and the electronic medicines compendium (eMC). It will be republished once Sandoz has a granted variation to its marketing authorisation for the new text. In the meantime, corrected dosing information supplied by Sandoz is given in Annex 1 of the notification, and healthcare professionals are told not to use the Sandoz SmPC to calculate weight-adjusted doses.

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 diarrhoea, nausea, vomiting and abdominal pain, dehydration and fluid and electrolyte disturbance, and hypersensitivity or other adverse reactions. Amoxicillin crystalluria, including acute renal injury or failure, is described as very rare and mainly linked to parenteral therapy. Patients should keep taking the medicine as prescribed and seek prompt medical advice if they think they received the higher dose and have symptoms.

A post-publication note says the Medicine Details table first gave the wrong strength; the correct strength is 250/62.5 mg/5 mL. The DMRC reference is DMRC-41234128. The MHRA's Class 4 category is its lowest-risk defect class, often described as caution in use.

What it means for your team

  • Prescribers and dispensers should use the corrected dosing in Annex 1 of the notification, not the withdrawn Sandoz SmPC, for weight-adjusted dosing of this product.
  • Pharmacovigilance teams may wish to watch for reports of gastrointestinal, hypersensitivity or renal events in children dosed with this suspension that could reflect the erroneous table.
  • Regulatory affairs teams should note that the corrected SmPC will only reappear on the MHRA and eMC sites after the variation is granted, leaving an interim gap in the official product information.
  • Quality teams should note that the issue concerns product information, not product quality; the notification does not report a quality defect in the powder.

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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