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WASHINGTON (AP) -- A nasal spray decongestant sold nationally is under recall because officials have found it was contaminated with harmful bacteria, the manufacturer said Friday.
Propharma Inc. , based in Miami, issued the recall of 39,540 bottles of Major Twice-A-Day 12 Hour Nasal Spray after a hospital in Colorado reported infections and found a germ, Burkholderia cepacia, in the product. A Food and Drug Administration analysis later confirmed it after finding the germ in unopened bottles from the lot.
Burkholderia cepacia can cause potentially life-threatening infections in persons with compromised immune systems and individuals with cystic fibrosis. The manufacturer said the only reports of infections were from the Colorado hospital.
The recalled bottles are marked with the lot number K4496, Exp. 10/06, and were distributed by Major Pharmaceuticals of Livonia, Mich. Bottles with other lot numbers aren't affected by the recall.
Consumers can return the product to the place of purchase for a refund. Those with questions can call a complaint line at Major Pharmaceuticals: (734)743-6181.
(Copyright 2004 by The Associated Press. All Rights Reserved.)