OTC Eye-Drop Maker Signs Consent Decree

December 1, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

OTC Eye-Drop Maker Signs Consent Decree

On Tuesday, Nov. 29, MBI Distributing, Inc. (MBI, Benicia, CA), also known as Molecular Biologics, signed a consent decree with the US Food and Drug Administration, in which MBI agreed to stop manufacturing its over-the-counter eye drops and other products until it corrects manufacturing deficiencies at its Benicia plant, according to an FDA statement.

The affected products include eye drops (“Oxydrops”, “Bright Eyes,” “Bright Eyes II,” “Clarity Vision for Life,” “Visitein,” and “Can-C”) and several analgesics.

The agency cited particularly that “the firm lacked manufacturing controls to ensure that its eye drops were sterile,” and contended that the Visitein and Clarity Vision for Life eye-drops were are unapproved drugs, and that three pain-relievers (“Biogesic,” “Bio-Ice,” and “Bio-Heat”) provided inadequate label warnings.

Under the terms of the consent decree-submitted to the US District Court for the Eastern District of California-“MBI is enjoined from producing and distributing drugs until the firm corrects the manufacturing violations for its eye drops and its violations of the marketing approval and labeling requirements of the Federal Food, Drug, and Cosmetic Act.”