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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Propharma, Inc. Recalls Major Twice-A-Day 12 Hour Nasal Spray - Nasal Decongestant

 

Contact:
Ray Farinas
305-592-9216

 

FOR IMMEDIATE RELEASE --Miami, FL -- March 18, 2004 -- Propharma, Inc., Miami, Florida is recalling"Major Twice-A-Day 12 Hour Nasal Spray - Nasal Decongestant, 1/2 oz. bottle, Lot #K4496, Exp 10/06 because the lot is contaminated with a type of bacteria called Burkholderia cepacia. Use of this contaminated product could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis.

This product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%, the lot number and expiration date are found on the bottom of the carton and the back of the bottle label.

The entire lot has been distributed nationwide to wholesalers, pharmacies, hospitals and retailers by Major Pharmaceuticals, Livonia, MI 48150. Major Pharmaceuticals has initiated a recall to the consumer level.

Propharma was alerted to this problem following reports of infections and findings of Burkholderia cepacia in the nasal spray by a hospital in Colorado. FDA sample analysis confirmed the presence of the bacteria in unopened bottles from the affected lot.

Consumers and retailers that have the product should return it to their place of purchase for a full refund. Consumers with questions regarding the recall may contact Major Pharmaceuticals at 734-743-6181.

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Major Pharmaceuticals Press Release (March 26, 2004)