MBI Agrees to Stop Production at California Plant

WASHINGTON —  A manufacturer of eyedrops and painkillers has agreed to stop production at its California plant after the Food and Drug Administration cited the company for safety and other problems.

The FDA announced Tuesday that MBI Distributing Inc., also known as Molecular Biologics, would no longer make or distribute its drugs until it corrected the violations at its Benicia, Calif., plant. The company agreed to these conditions in a consent decree that still must be approved by a federal court, the agency said.

According to the FDA, the problems with the company’s products include:

* Eye drops that are not manufactured according to national standards. The company lacks controls to ensure its eye drops are sterile, the agency said. Eye drops made by the company and distributed nationally are sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein and Can-C.

* Two eye drop brands, Visitein and Clarity Vision for Life, that are unapproved drugs.

* Three pain relievers, Biogesic, Bio-Ice and Bio-Heat, that do not carry adequate warnings regarding their safe use.

“The firm’s poor manufacturing conditions have called into question the safety of its eye drops, and the lack of necessary warnings could undermine the ability of a consumer to safely use the firm’s pain relieving drugs,” the agency said in a statement.

The FDA recommended people throw away these products.

BMI President Ned Jensen disputed many of the FDA’s contentions but said the company was taking steps to bring its products in line with the agency’s findings.