Drug company recalls Eye-Mo drops

By: Tina G. Santos - 10 years ago

SCREENGRAB from www.fda.gov.ph

MANILA, Philippines—The pharmaceutical company GlaxoSmithKline Philippines Inc. has 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.

In an advisory, the FDA said 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 (Tianjin) Co. Ltd. – China.

The affected batches include Batch No. 12045175 and 12045176 with expiry date March 2015; 12045252 to 53, and 12055036 to 38 with expiry date April 2015; 12055211 to 12, May 2015; 12075012 to 13, June 2015; 12075171 to 72 and 12075206 to 07, July 2015; 12085215 to 19 and 12095099 to 100, August 2015; 12095198, 12095235 and 12105060, September 2015; 12115148, October 2015; 12115216 to 18, November 2015; 13015107 to 09, December 2015.

Other batches covered by the product recall include Batch No. 13015224, 13025035 and 13015274, with expiry date January 2016; 13035142 to 44 and 13035179 to 80, February 2016; 13045131 to 32, March 2016; 13045183 to 84 and 13055078 to 80, April 2016; 13055230 to 33 and 13065053 to 54, May 2016; 13075013 to 16, June 2016; 13085027 to 28, July 2016; 13095061, August 2016; 13095062 and 13105001 to 02, September 2016; and 13105223 to 24, October 2016.

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.

The FDA instructed distributors, retailers, hospitals and pharmacies or clinics that have the affected batches of Eye-Mo to discontinue further distribution, sale and use.

Likewise, all field Food and Drug Regulation Officers were ordered to monitor the availability of the product batches in the market, the FDA said.

It also urged consumers to immediately report any adverse reaction experienced from using the eye drops product.