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FDA STATEMENT

FOR IMMEDIATE RELEASE
May 14, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Announces Recall of "DU" Brand Nasal Decongestant Due To Possible Health Risk

FDA today alerted consumers not to purchase or use a recalled lot of DU brand nasal decongestant spray (distributed by Drugs Unlimited, of Puerto Rico) because it may be contaminated with Burkholderia cepacia – a bacterium that could cause serious, potentially life-threatening infections in some patients. Individuals with compromised immune systems, especially those with cystic fibrosis, could be at risk.

The recalled product is sold over the counter in 15 milliliter (or “1/2 ounce”) and 30 milliliter bottles labeled “DU 12-Hour Nasal Spray” with the lot number J4492 imprinted at the bottom of the carton and the back of the bottle label. The recalled product also bears an expiration date of 9/06.

The product appears to have been distributed throughout Puerto Rico and it is likely linked to an earlier recall of other contaminated product lots that were sold to other distributors.

Consumers who have used the recalled product may want to consult their physicians. Consumers who may still have the recalled product should not use it, but instead return it immediately to the stores where it was purchased. Wholesalers and retailers who purchased the product should return it to the appropriate distribution center. Anyone needing more information can call Rey Farinas at 305-592- 9216.

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