FDA: Batches of eye drop solution recalled

Consumers may want to avoid buying a specific batch of eye drops after they were recalled from the market, the Philippine Food and Drug Administration said.

The FDA, in Advisory 2014-074, said the batches of tetrahydrozoline hydrochloride (Visine) 0.5 mg/ml (0.05 percent) were involved in the recall.

It said the recall stemmed from the statement of non-compliance with good manufacturing practice issued by the Italian Medicines Agency to the maker of tetrahydrozoline hydrochloride, the product's active ingredient.

"The active pharmaceutical ingredient, tetrahydrozoline hydrochloride, was used in the manufacture of the specific batches of Visine Ophthalmic Solution (eye drops) by PT Pfizer Indonesia," it said.

Recalled were batch numbers 329-67013, 329-67026, 329-67038 and 429-67018 made by PT Pfizer Indonesia and imported in the Philippines by Johnson & Johnson (Philippines) Inc. 

FDA head Kenneth Hartigan-Go said FDA regulation officers have orders to monitor the product in the market.

He asked distributors and retailers and pharmacies or clinics that have the affected batches to "discontinue further distribution, sale and use."

Consumers may contact Johnson & Johnson at 8247901 or email FDA at info@fda.gov.ph.

Last August, pharmaceutical firm GlaxoSmithKline recalled some batches of Eye-Mo Red Eyes Formula 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. — Joel Locsin /LBG, GMA News