Eye Drops Recalled Due to Production Conditions and Sterility Concerns

Two months ago, the U.S. Food & Drug Administration (FDA) posted information about a California firm recalling specific lots of eye relief drops. The recall was announced due to a recent FDA inspection. According to the notice, investigators observed that ophthalmic drugs, which are required to be sterile, were being manufactured without necessary production controls and conditions to assure sterility.

The recalled product is an over-the-counter (OTC) homeopathic eye drop. The company states its use is for the temporary relief of burning and irritation due to dryness of the eye and discomfort due to minor irritations of the eye or to exposure to wind or sun. Fortunately, at the time of the recall notice, the manufacturer had not received any reports of adverse events related to this product. Customers are being advised to not use it and for distributors to not sell the lots within expiration.

The scientists at MPL Laboratories offer sterility testing services. Their dedicated FDA registered and Drug Enforcement Administration (DEA) licensed facility offers cGMP and ISO 17025 compliant sterility and microbiology testing of homeopathic products, pharmaceuticals, cosmetics and personal care products.

MPL’s services take place in a controlled environment room that is continuously monitored and features restricted access to assure the highest quality results. 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 before these items reach consumers, patients or healthcare providers. Testing services are available to manufacturers, importers, distributors, retailers, regulatory agencies and healthcare providers.

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