London-listed pharmaceuticals giant GlaxoSmithKline (GSK) has launched a voluntary recall of several batches of its Eye-Mo Red Eyes Formula Ophthalmic Solution, the U.S. Food and Drug Administration (FDA) said in a statement over the weekend.
Eye-Mo drops are 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. The solution is sold in 7.5mL plastic containers.
The FDA said the product recall was in response to a statement of non-compliance with "Good Manufacturing Practice," issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci (SIMS).
SIMS is the manufacturer of the active pharmaceutical ingredient Tetrahydrozoline HCI, which was used in the manufacture of Eye-Mo by GSK in China.
The FDA is instructing distributors, retailers, hospitals, pharmacies or clinics that have affected batches of the solution to discontinue further distribution, sale and use of the Eye-Mo drops.
"All the field Food and Drug Regulation Officers are ordered to monitor the availability of the product batches in the market," the FDA said.
A list of the affected batches is published on the FDA website.