Nov. 20, 2009 - Procter & Gamble has recalled some 120,000 bottles of Vicks Sinex nasal spray because of possible bacterial contamination.
Three lots of the product are affected. The recalled products were distributed in about equal amounts, nationwide, in the U.S., the U.K., and Germany.
The contamination was discovered in nasal spray being made at P&G's plant in Gross Gerau, Germany. Testing also identified the contamination in the lot of product distributed in the U.S.; tests of the U.K. and German products are ongoing.
The affected products are:
Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml, Nasal Spray
Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml
Wick Sinex Schnupfenspray Dosiersystem, 15 ml
The product's lot number is listed on both the outer carton and the bottle.
If you have one of the affected bottles, throw it out. P&G offers to replace the product or to refund the cost of the product; for more information, U.S. consumers can call 877-876-7881.
P&G has not received any reports of illness due to the contamination, but it is recalling the product to ensure consumer safety, says Crystal Harrell, global external relations manager for Vicks.
"If people are normally healthy, they should be OK even if they used the affected product -- but if they are concerned, they should see their health care provider," Harrell tells WebMD. "We want people with weak or compromised immune systems or with lung disease to be aware of the dangers."
The contaminant found at the German plant is Burkholderia cepacia, a group of bacteria found in soil and water. These bacteria can be resistant to commonly used antibiotics.
However, B. cepacia poses little risk to healthy people. Infection does pose a risk to people with weakened immune systems or those with lung disease -- particularly those with cystic fibrosis. B. cepacia also causes infections in hospitalized patients.
Infection with B. cepacia can cause severe respiratory infections. Because this bug can be antibiotic resistant, treatment decisions are made on a case-by-case basis.
This isn't the first time this bug has found its way into nasal spray. It was linked to a 2004 recall of "Major Twice-A-Day 12 Hour Nasal Spray" made by Propharma Inc.
If you think you've experienced a health problem linked to use of the Vicks nasal spray, call your health care provider and report your experience to the FDA's MedWatch program at 800-FDA-0187 or at www.fda.gov/medwatch.