Major Twice-A-Day 12 Hour Nasal Spray

March 26, 2004

Audience: Pharmacists and consumers

Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-Day 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was contaminated with Burkholderia cepacia bacteria. This product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%. The entire lot was distributed nationwide to wholesalers, pharmacies, hospitals and retailers. Use of this contaminated product could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis. The lot number and expiration date are found on the bottom of the carton and the back of the bottle label.

[UPDATE March 26, 2004 Press Release - Propharma]
[March 18, 2004 Press Release - Propharma]

View comments

Hide
(web5)