TUESDAY, Nov. 29 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday that MBI Distributing, Inc., also known as Molecular Biologics, has signed a consent decree requiring it to stop making eye drops and other drugs until it corrects problems in its Benicia, Calif., facility.
Consumers and health care providers should dispose of Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision For Life, Visitein, and Can-C brand eye drops, as well as Biogesic, Bio-Ice and Bio-Heat pain relievers. Adverse effects can be reported to MedWatch at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm, the federal agency says.
MBI agreed to correct "poor manufacturing conditions" that could affect the sterility of its eye drops. It will also beef up warning labels for its over-the-counter pain relievers, according to an FDA statement. The decree is subject to approval by the U.S. District Court for the Eastern District of California.
The FDA took action after determining that the firm's eye drop manufacturing procedures failed to ensure sterility, according to an FDA statement. Two of the firm's top eye drops, Visitein and Clarity Vision For Life, are unapproved; and three pain-relieving drugs -- Biogesic, Bio-Ice and Bio-Heat -- do not carry adequate warnings, according to the FDA statement.
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