The Food and Drug Administration (FDA) has ordered MBI Distributing, Inc. (MBI), also known as Molecular Biologics, to stop production of its over-the-counter (OTC) eye drops and pain relievers.
A consent decree obtained by the FDA shuts down the company which has been found to not be in compliance with FDA manufacturing standards. These deficiencies and other violations have raised concerns as to the safety of the company’s eye drops. Inadequate warnings have also called into question whether consumers can safely use the company’s pain relievers.
The FDA has ordered that BMI stop production until violations found at the Benicia, California, factory are corrected. The agency reports the company has not responded to previous requests to come into compliance with federal standards and that the most current inspection indicated that the firm was not instituting the proper manufacturing controls to maintain sterility in their eye drops.
The FDA also warns that two brand of eye drops, Visitein and Clarity Vision for Life, are unapproved drugs and that the company’s OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, are not labeled with the proper warnings to ensure consumer safety.
Consumers, health care providers, and caregivers are advised to discard the following eye drops: Oxydrops; Bright Eyes; Bright Eyes II; Clarity Vision for Life; Visitein; and Can-C as well as the pain relievers Biogesic, Bio-Ice, and Bio-Heat.
The FDA’s action prevents the manufacturer from producing eye drops or drugs until its factory and labeling operations are brought into compliance with the Federal Food, Drug, and Cosmetic Act.
Any adverse events related to these products should be reported to MedWatch, the FDA’s voluntary reporting program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.
The consent decree was submitted to the U.S. District Court for the Eastern District of California by the Department of Justice on behalf of FDA and is subject to approval by the court.
This is the second pharmaceutical company to be shut down by way of a consent decree in recent months. Earlier this year, the FDA shut down the leading generic drug manufacturer, Able Labs.
In a scathing 15-page report to Able Laboratories dated July 6, 2005 and posted on the company’s website (http://www.ablelabs.com/FDA/483.pdf), the FDA revealed that its drastic enforcement action was the result of agency inspectors having found massive record falsification and mismanagement by Able in order to elude FDA detection of several defective medications.