GSK recalls batches of Eye-Mo for ‘noncompliance’ with standards

Pharmaceutical firm GlaxoSmithKline is recalling several batches of its Eye-Mo Red Eyes Formula Ophthalmic Solution, the Food and Drug Administration said over the weekend.

The FDA, in Advisory 2014-066, said the recall covers batches of Tetrahydrozoline HCl 0.05% Ophthalmic Solution with registration number DRHR-431.

It said this stemmed from the noncompliance with good manufacturing practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, the maker of Tetrahydrozoline HCl.

"The active pharmaceutical ingredient Tetrahydrozoline HCl was used in the manufacture of Eye-Mo Red Eyes Formula Ophthalmic Solution by GlaxoSmithKline (Tianjin) Co. Ltd. China," it said.
A list of the affected batches was posted on the FDA website.

With the advisory, the FDA advised distributors, retailers, hospitals, pharmacies or clinics with the affected batches to stop further distribution, sale and use.

Field FDA officers also have orders to monitor the batches.

Tetrahydrozoline HCl is used for relief of eye redness and minor discomfort caused by dust, smoke, wind, sun glare, swimming and lack of sleep, FDA said. — Joel Locsin/JDS, GMA News