The Spanish Agency for Medicines and Health Products (Aemps), attached to the Ministry of Health, has announced the withdrawal from the market of all units distributed in batch CP3W of the antibiotic Augmentin 100 mg/ml + 12.5 mg/ml powder for oral suspensionl. This medicine, distributed in 40 ml bottles, has an expiry date of August 31, 2025. The decision responds to the detection of a “defect” in the sealing of certain bottles, according to the alert issued by Aemps.
Despite the quality defect, Aemps stressed that the problem “does not pose a mortal risk to the patient”although it has urged to withdraw from the market all affected units as a precautionary measure. The autonomous communities must guarantee the monitoring of the withdrawal, while the return of the affected products to the laboratory has been requested through the usual channels.
Augmentin, an antibiotic that combines amoxicillin and clavulanic acid, is manufactured by the French company Glaxo Wellcome Production, while the marketing authorization property belongs to GlaxoSmithKline, SA. This medicine is used in the treatment of bacterial infections in adults and children.
