FDA: Batches of eye drop recalled

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Saturday, August 30, 2014


THE Food and Drug Administration (FDA) announced Saturday the voluntary recall of particular batches of popular eye drop, Eye-Mo Red Eyes Formula.

Based on FDA Advisory No. 2014-066, GlaxoSmithKline Philippines, Inc. has initiated a product recall of Tetrahydrozoline HCl 0.05 percent Ophthalmic Solution (Eye-Mo Red Eyes Formula) with Registration Number DRHR-431.

"This is in response to the statement of non-compliance with Good Manufacturing Practice (GMP) issued by the Italian Medicines Agency (AIFA) to the Societa Italiana Medicinali Scandicci, srl. (SIMS), the manufacturer of the active pharmaceutical ingredient, Tetrahydrozoline HCl," said the FDA.

The agency said the active pharmaceutical ingredient, Tetrahydrozoline HCl, was used in the manufacture of Eye-Mo Red Eyes Formula.

The FDA, though, said no other batches of Eye-Mo Red Eyes Formula are included in the voluntary recall.

Eye-Mo is an eye drop used for relief of eye redness and minor discomforts caused by irritants such as dust, smoke, wind, and sun glare. (Sunnex)

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