IGMPI India

GlaxoSmithKline Philippines Inc. initiated a voluntary recall of specific batches of its eye drops product, Eye-Mo Red Eyes Formula Ophthalmic Solution. According to the Food and Drug Administration, the product recall was in response to the statement of non-compliance with Good Manufacturing Practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, srl (SIMS).

SIMS is the manufacturer of the active pharmaceutical ingredient tetrahydrozoline HCl, which was used in the manufacturing of Eye-Mo Red Eyes Formula Ophthalmic Solution by GlaxoSmithKline Co. Ltd. Eye-Mo is used for the relief of eye redness and minor discomfort caused by irritants such as dust, smoke, wind, sun glare, swimming and lack of sleep. It is packed in a plastic container containing 7.5 ml solution.

All field Food and Drug Regulation Officers were also ordered to monitor the availability of the product batches in the market. Also consumers wereadvised to immediately report any adverse reaction experienced from using the eye drops product.