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Recall of twice a day 12 hour nasal decongestant

On March 18, 2004 the FDA announced Propharma, Inc., Miami, Florida would be recalling "Major Twice-A-Day 12 Hour Nasal Spray, in ½ oz. bottle sizes, from lot 3K4496, Exp 10/06." Also, on March 26, Major Pharmaceuticals, Livonia, MI announced their voluntary recall of 15 ml and 30 ml bottles of "Major Soothing Twice-A-Day Nasal Spray" with the following lot numbers: E4410, F4433, H4464, K4496, L4529, L4535, M4536, A4558, and B4597.

Some nasal sprays from these lots were found to be contaminated with a type of bacteria known as Burkholderia cepacia. Burkholderia cepacia is a gram-negative bacteria found worldwide. It is particularly well known as an opportunistic pathogen in hospital settings. Use of the contaminated product could lead to a serious or potentially life-threatening infection in immunocompromised patients, especially patients with cystic fibrosis. Healthy patients are still at risk for developing an infection if they use the contaminated product, however, the infection will likely not be as severe.

Twice-A-Day 12 Hour Nasal Spray is an over-the-counter nasal decongestant that contains oxymetazoline hydrochloride 0.05%. The lot number and expiration date can be found on the bottom of the package and on the back of the bottle label.

Healthy patients who have used the contaminated product should watch for signs of respiratory tract infection (fever, sinus-pain, cough, congestion, increased heart rate and malaise) and contact their physician if these symptoms occur.

Patients who are immunocompromised, have cystic fibrosis, have had a recent organ transplant, or are taking immunosuppressive medications should contact their physician immediately if they have used the contaminated product.

Consumers that have the product should return it to their place of purchase for a full refund. Hospitals and retailers should contact their distributors for return procedures. Questions regarding the recall may be directed to Major Pharmaceuticals at 734-743-6181.

References:

1. www.fda.gov
2. Micromedex

Morgan Watkins, PharmD. Candidate