Visine. Photo by MorePix/ https://en.wikipedia.org
MANILA, Philippines—The Food and Drug Administration announced Friday that specific batches of the eye drops Visine were being pulled out from the market after the Italian Medicines Agency stated that the manufacturer of an active ingredient in the product did not comply with good production practice.
In FDA Advisory No. 2014-074, FDA acting director general Kenneth Go warned the public against buying or using Visine Ophthalmic Solution with batch numbers 329-67013, 329-67026 and 429-67018.
The eye drops product was manufactured by PT Pfizer Indonesia and imported and distributed by Johnson and Johnson (Philippines), Inc.
Go said the recall was ordered following the statement of non-compliance with GMP issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, srl. (SIMS), the manufacturer of the active ingredient, Tetrahydrozoline Hydrochloride.
This ingredient was used in the manufacture of the specific batches of Visine being pulled out from the market, said the FDA official.
GMP is the collective name of the practices necessary to conform to guidelines recommended by regulating and licensing bodies for the manufacture and sale of food, drug and pharmaceutical products to ensure that these products are safe for the public and are of high quality.
Visine is used for the relief of eye redness due to minor irritations caused by plant and pollen allergies, smog, smoke, dust, wind and other eye irritants. The product is packed in a plastic bottle containing 6 ml solution plugged with pilfer-proof cap.
“The affected products presents safety risk and potential adverse health consequences,” the FDA advisory said.
The agency also instructed distributors, retailers, hospitals, pharmacies and clinics that have the affected batches of Visine to discontinue further distribution, sale and use.
All field Food and Drug Regulation Officers were ordered to monitor the presence of the product batches in the market.
The FDA also advised consumers to contact Johnson and Johnson (Philippines), Inc. at telephone number +632 824-7901 or email the agency at info@fda.gov.ph for further queries or additional information about the recall.