A manufacturer of eye drops 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 yesterday that MBI Distributing Inc., also known as Molecular Biologics, will no longer make or distribute its drugs until it corrects 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 brands of eye drops, 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 is taking steps to bring its products into line with the agency's findings.
The company expects to be able to return to producing many of its products in a few months when a new manufacturing facility is completed, he said. The firm has already changed warning labels on its painkiller products, he said.