Worldwide Recall of an Eye Drop Product Due to Sterility Concerns and Undeclared Ingredient

Recently, the U.S. Food & Drug Administration (FDA) posted information about a voluntary recall of eye drops manufactured in Utah that were distributed nationally and internationally. The recall was announced after a recent FDA inspection which found the product was manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

According to the notice, use of a non-sterile eye drops could result in a potentially sight threatening eye infection. Exposure to colloidal silver, over an extended period of time, could result in permanent discoloration of the conjunctiva. Fortunately, at the time of the FDA recall posting, the company had not received any reports of adverse events related to the product lots in question. This recall includes health practitioners, retail and consumer levels.

In November of last year, a California firm also recalled specific lots of eye relief drops. That recall was similarly announced due to an FDA inspection. In that case, investigators observed that ophthalmic drugs, which are required to be sterile, were being manufactured without the necessary production controls and conditions to assure sterility.

Working diligently to help prevent these types of costly recalls and protect consumers from products with potential contamination issues are the scientists at MPL Laboratories. Their dedicated FDA registered and DEA licensed facility offers cGMP and ISO 17025 compliant sterility and microbiology testing of homeopathic products, pharmaceuticals, cosmetics and personal care products. The laboratory is staffed with renowned scientists that have access to advanced instrumentation that allows them to rapidly identify issues in the manufacturing process or the actual product that could cause sterility or other product quality issues.

To learn more about this or other homeopathic, pharmaceutical, cosmetic or personal care product testing services provided by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874 or email  info@mpllaboratories.com .


About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full service microbiology laboratory. It is ISO/IEC 17025 accredited by PJLA, FDA and DEA registered, and NJDEP certified. MPL’s staff includes a PhD Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, medical device, cosmetic, personal care and food industries. MPL aims to provide its clients with high quality, reliable test data in a timely manner. The laboratory is part of the EMSL Analytical network of over 40 laboratories across the United States and Canada.

Contact Information

Joseph Frasca

Senior Vice President of Marketing

MPL Laboratories

(1) 856-303-2503

Contact via E-mail