THE pharmaceutical firm GlaxoSmithKline (GSK) Philippines Inc. has ordered the recall of a batch of its antibiotic product after finding defects in bottle seals, according to the Food and Drug Administration (FDA).
It said the firm “pursued the voluntary recall” of “Co-Amoxiclav 457 mg/5 ml powder for suspension 35 mL [Augmentin]” with Batch No. ET4E and expiry date 10/2025 “due to a defect in the seal of the impacted bottles.”
Co-Amoxiclav is used for short-term treatment of bacterial infections when caused by amoxicillin-clavulanate-susceptible organisms. These include recurrent tonsilitis, sinusitis, otitis media, acute exacerbations of chronic obstructive pulmonary disease /acute exacerbations of chronic bronchitis, lobar and bronchopneumonia, cystitis, urethritis, pyelonephritis, female genital infections, gonorrhea, among others.
The FDA said the defect in the seal could lead to the degradation of the ingredients of the antibiotic.
“This could potentially affect the efficacy of the product, thereby causing adverse effect to the patient. It could either be toxic or it might fail to treat the infection,” said the FDA.
With the recall order, the agency said all distributors, hospitals, retailers, pharmacies, or clinics that have the product are instructed to discontinue further distribution, sale, and use.
