<<Disclaimer: Verify this information before applying it to your situation.>>

On Tuesday, September 16, 2008, the US Food and Drug Administration issued 
a warning to Ranbaxy, an Indian company that makes generic drugs, and 
imposed an import alert on drugs coming into the US from two of the 
company’s facilities.  The action was due to the manufacturer’s non-
compliance with Good Manufacturing Practice requirements and improper 
record-keeping (such as “Inaccurate written records of the cleaning and use 
of major equipment”).  At this time, the FDA is not pulling Ranbaxy’s products 
from pharmacy shelves as it believes that supplies of Ranbaxy drugs currently 
in the US are safe.  However, WebMD points out, “This is the second time in 
less than three years that the FDA has issued a warning letter to Ranbaxy,” 
which indicates that the company has had problems in the past. 
The FDA reports that “Ranbaxy is one of the largest foreign suppliers of 
generic drugs to the United States.”

In light of the recent ban, I considered a look in our home medicine cabinet to 
be warranted.  Despite the FDA’s assurance of the safety of Ranbaxy drugs 
already in the US, I planned to ask my doctor for a replacement from another 
manufacturer if I found Ranbaxy products in my house, especially since 
inadequate sterilization and cross-contamination were two of the FDA’s 
complaints against the company.  Although I found one generic drug matching 
the name of a product on the FDA ban list, the manufacturer of our 
prescription was Apotex, a Canadian company.  The pharmacy had included 
supplier information on their printed label.  Had the information not been on 
the label, I could have called the pharmacist to find out the manufacturer.

You can see the FDA report and find a link to the banned drug list at
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html.
If you prefer something a little easier to read and understand, try these links:  
http://www.forbes.com/markets/2008/09/16/ranbaxy-fda-generic-markets-
equity-cx_lal_0916markets39.html
http://www.webmd.com/news/20080916/import-alert-for-2-generic-drug-
plants?src=RSS_PUBLIC
http://www.pharmaceuticalonline.com/article.mvc/FDA-Issues-Warning-
Letters-To-Ranbaxy-0001?atc~c=771+s=773+r=001+l=a&VNETCOOKIE=NO 

Deborah Holladay
Alamo Celiac GIG Membership Database

Visit the Celiac Web Page at Http://www.enabling.org/ia/celiac/index.html
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