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Senior Alert
Eye Drop Maker Agrees to FDA Order to Stop
Manufacturing Products
Nov. 29, 2005 - The U.S. Food and Drug
Administration (FDA) yesterday announced that MBI Distributing, Inc. (MBI)
has agreed to cease manufacturing and distributing drugs until it
corrects manufacturing deficiencies. Senior citizens should check to see
if they have any of these eye drops - Oxydrops, Bright Eyes, Bright Eyes
II, Clarity Vision for Life, Visitein or Can-C. MBI also makes OTC pain
relieving drugs, including Biogesic, Bio-Ice and Bio-Heat.
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Update to this story |
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The story below
refers the news report on this page.
Eye Drop Maker Threatens to Sue SeniorJournal.com
Over Senior Alert
By Tucker Sutherland,
editor
Jan. 29, 2006 – Jeff Jensen, vice president of MBI
Distributing, an OTC drug manufacturer of eye drops and other products,
has emailed SeniorJournal.com threatening legal action against the Web
site if it does not remove from its site a "Senior Alert" article from
last November that warned seniors about dangers from certain of their
eye drop products based on information from the Food and Drug
Administration.
"This article contains incorrect and slanderous
information," wrote Jensen. "MBI Distributing continues to manufacture
drugs in compliance to FDA manufacturing standards."
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These products are sold by retailers nationwide and
manufactured at the company's plant in Benicia, California.
This action is a result of FDA having determined
that the firm has been manufacturing eye drops in a manner that does not
conform to FDA's current good manufacturing practice requirements.
The firm has not corrected violations noted during
inspections, despite Agency efforts to have the company achieve
compliance. Among other things, at FDA's most recent inspection, the
firm lacked manufacturing controls to ensure that its eye drops were
sterile.
MBI is also known as Molecular Biologics and is an
OTC drug manufacturer of eye drops and other products,
FDA has also determined that two of the firm's eye
drop brands, Visitein and Clarity Vision for Life, are unapproved drugs.
In addition, three of the firm's OTC pain relieving drugs, Biogesic,
Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe
use.
Under the terms of the consent decree, 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.
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 listed above.
FDA therefore recommends that consumers, health
care providers, and caregivers dispose of the Oxydrops, Bright Eyes,
Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of
eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs
and report any adverse events related to these products 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.
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