News
06/19/1992

<TITLE>Recall of Injectable and Ophthalmic Drug Products</TITLE>
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P92-18                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Faye Peterson - (301) 443-3285
    The Food and Drug Administration today announced that For Your Health,    
Inc., of Kent, Wash., is undertaking a nationwide and international recall    
of all lots of its injectable and ophthalmic drug products because of mold    
and other microbial contaminants detected by FDA in some samples.
    In FDA tests so far, two of the company's products -- intravenous         
solutions of "magnesium-ATP" and "Solu-Cortef" -- have been found to be       
contaminated with mold.  (Solu-Cortef is an approved product manufactured     
and distributed by The Upjohn Co. of Kalamazoo, Mich.  There are no known     
problems with Upjohn's product.  This recall applies only to Solu-Cortef      
that was repackaged and distributed by "For Your Health Pharmacy.")           
Injection or intravenous use of these products could result in systemic       
bacterial or fungal infections that might be life threatening in patients     
whose health is already poor due to other diseases or an impaired immune      
system.
    Other products under recall because "For Your Health Pharmacy" did not    
have adequate controls to assure they are sterile include:  
    chromium liquid in glass vials (injectable)
    copper liquid in glass vials (injectable)
    manganese liquid in glass vials (injectable)
    selenium liquid in glass vials (injectable)
    vanadium liquid in glass vials (injectable)
    zinc liquid in glass vials (injectable)
    molybdenum liquid in glass vials (injectable)
    trace mineral in glass vials (injectable)
    vitamin A and C eye drops (liquid in plastic eye drop bottles)
    saline solution in l00 ml glass vials, possibly labeled "Normal Saline    
0.9% NaCl" followed by a batch number (injectable)
    glutathione in glass vials, possibly labeled in part "Glutathione         
600mg/vial" followed by a lot number and an expiration date (to be            
reconstituted for injection)
    Labeling for each product varies.  Some of the labels may include the     
name "For Your Health Pharmacy" or "Tahoma Clinic."  The products, however,   
may have no label attached nor include the firm's name.
    Complete distribution records from the manufacturer are not available;    
therefore, FDA is also unable to verify all the names and locations of        
consignees, the quantity of products distributed or the amount that remains   
on the market.  
    FDA became aware of the distribution and potential danger of these        
products on May 6, l992, when the agency -- together with the U.S. Attorney   
and local law enforcement officials -- executed a search warrant at the       
firm.  FDA conducted sterility testing on samples of drugs produced at the    
pharmacy because the manufacturing facility lacked proper controls to ensure  
product sterility.
    FDA advises wholesalers, retailers, physicians or consumers who have any  
of these products to return them immediately to For Your Health, Inc., l32l5  
SE 240th St., Kent, Wash. 98042.  People needing further information about    
the identity of the products may telephone the company at 206-63l-0636.
    FDA is one of the eight Public Health Service agencies within HHS.
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