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.
Major Pharmaceuticals Announces an Extension of its Nationwide Voluntary Recall of Twice-A-Day 12 Hour Nasal Decongestant to Cover Additional Lots
FOR IMMEDIATE RELEASE -- Livonia, MI -- March 26, 2004 -- Major Pharmaceuticals said today that it is conducting a voluntary Class I recall of certain lots of Twice-A-Day Nasal Spray 15 ml and 30 ml bottles. The recall of one lot was announced last week in a press release issued by Propharma, Inc. of Miami, FL. The product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%. The product is contaminated with a type of bacteria called Burkholderia cepacia. Some of the recalled lots have been found to be contaminated and could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis.
The product being recalled is an over-the-counter drug product labeled "Major Soothing Twice-A-Day 12 Hour Nasal Spray Decongestant Regular Oxymetazoline Hydrochloride 0.05%. Distributed by Major Pharmaceuticals, Livonia, MI". The lot number can be found on the bottom of the carton and on the back of the bottle label. The lot numbers being recalled are E4410, F4433, H4464, K4496, L4529, L4535, M4536, A4558, A4588, and B4597.
Major said it is working cooperatively with the U.S. Food and Drug Administration to implement a nationwide recall, in the interest of consumers, as quickly and as efficiently as possible.
Consumers should return the product immediately to the stores where it was purchased. Wholesalers and retailers who purchased the product from Major directly should return it to the appropriate distribution center. Anyone needing more information from Major may call customer service at 734-743-6181.
Propharma Press Release (March 18, 2004)