Sandoz co-amoxiclav prescribing document pulled in UK over dosing table error

Sandoz has had the UK prescribing document for one of its co-amoxiclav products taken offline after the company reported a mistake in it. The MHRA published the Class 4 notice, reference EL(26)A/46, on 5 November 2026. It covers Co-amoxiclav 250/62.5 mg/5 ml powder for oral suspension (PL 04416/0515), for which Sandoz Limited holds the marketing authorisation.

The error sits in the table in Section 4.2 of the summary of product characteristics (SmPC), which tells prescribers how much suspension to give according to a patient's weight. According to the regulator, the volumes listed would deliver roughly twice the intended dose. The notice stresses that the powder itself has no quality problem. Because the fault is in the text rather than in any production run, every batch on the market is in scope.

The SmPC has been removed from the MHRA's products site and from the electronic medicines compendium. A corrected version will go up only after Sandoz secures a variation to the marketing authorisation. Until then, clinicians are told not to calculate doses from the withdrawn document and should use the corrected dosing information Sandoz has supplied in Annex 1 of the notice.

The MHRA lists the risks of following the faulty table as a higher chance of dose-related effects: gastrointestinal upset such as diarrhoea, nausea, vomiting and abdominal pain, dehydration with fluid and electrolyte disturbance, and hypersensitivity or other adverse reactions. It also mentions amoxicillin crystalluria, including acute kidney injury or failure, but describes this as very rare and mainly seen with parenteral treatment. Patients are told to keep taking the medicine as prescribed. Anyone who may have received the higher dose and has symptoms should seek medical advice straight away.

The notice says nothing about recalls, supply interruptions or sales, and no financial impact has been disclosed. For context, Class 4 is the lowest tier in the MHRA's defect classification and is generally used where risk to patients is little or none.