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RECALL INJECTABLE AND OPHTHALMIC DRUGS

 RECALL INJECTABLE AND OPHTHALMIC DRUGS
 WASHINGTON, June 19 /PRNewswire/ -- The Food and Drug


Administration (FDA) 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)
 -- menganese 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 100 ml glass vials, possibly labeled "Normal Saline 0.9 percent 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, 1992, 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., 13215 SE 240th St., Kent, Wash. 98042. People needing further information about the identity of the products may telephone the company at 206-631-0636.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 6/19/92
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Faye Peterson of the Food and Drug Administration, 301-443-3285, or after hours, 301-596-9639/ CO: U.S. Food and Drug Administration ST: District of Columbia IN: MTC SU:


IH -- DC023 -- 2034 06/19/92 15:58 EDT
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Publication:PR Newswire
Date:Jun 19, 1992
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