Sandoz Limited has informed the MHRA of errors in the dosing table in the Summary of Product Characteristics for its co-amoxiclav powder for oral suspension 250/62.5 mg/5mL. The defective table, in Section 4.2, provided weight adjusted dosing instructions that would deliver approximately twice the intended, recommended dose. All batches are currently impacted. The quality of the powder itself is not affected.
The defective document has been removed from the MHRA products website and the electronic medicines compendium, and will return once Sandoz receives a granted variation for a corrected version. The MHRA told healthcare professionals not to use the Sandoz document for weight adjusted dosing and pointed them to corrected dosing information supplied by the company. Based on the defective instruction there is a potential for overdose, raising the likelihood of dose related effects including gastrointestinal symptoms, dehydration and hypersensitivity reactions. Amoxicillin crystalluria, including acute renal injury, has been reported but is described as very rare and predominantly associated with parenteral therapy. Patients were told to continue taking the medicine as prescribed and to seek immediate advice if they believe they took the higher dose and have symptoms.
In a separate Class 3 recall, Aspire Pharma is recalling three batches of tropicamide 1 percent eye drops in single dose containers (batches E941A, E941B and E941C) because they are labelled with an incorrect expiry date. The packs print 30 April 2027; the correct expiry date is 31 October 2026. Healthcare professionals were told to stop supplying the batches immediately, quarantine remaining stock and return it to the supplier.
The Aspire recall is being undertaken at pharmacy and wholesaler level as a precaution. Patients in possession of the batches should continue to use the eye drops and contact their prescriber for a replacement prescription. No reports of adverse incidents due to the defect have been received to date, the MHRA said.