Vicks Sinex Nasal Spray Recalled
The makers of Vicks Sinex Nasal Spray voluntarily recalled approximately 120,000 bottles after finding the bacteria Burkholderia cepacia in a small amount of the product made in Germany and sold in the United States. Thus far, no one has reported becoming ill after using the nasal spray.
According to the Centers for Disease Control and Prevention, B. cepacia is the name for a group of bacteria that are typically found in water and soil, although transmission of the organism from contaminated medicines and devices has been reported. These bacteria are often resistant to commonly used antibiotics. B. cepacia poses little health risk to people who are healthy, but individuals who have chronic lung conditions such as cystic fibrosis or whose immune system is weakened may be more susceptible to serious infection. The bacteria are a known cause of infections in hospitalized patients.
This is not the first time products have been involved with B. cepacia contamination. In 2005, the CDC was notified by several states of pneumonia and other infections caused by the bacteria associated with tainted mouthwash. A voluntary recall by Propharma Inc. of an over-the-counter nasal spray due to contamination with B. cepacia also occurred in 2004. The most recent recall was in September 2009 when several types of children's and infants' Tylenol were recalled for possible B. cepacia contamination.
The current recall involves three lots of Vicks Sinex Nasal Spray sold in the United States, Germany, and the United Kingdom. Thus far the bacteria were found in product from a lot sold in the United States, and Procter & Gamble is testing the German and UK lots that were made from the same batch of raw material. The US recall involves Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, lot number 9239028831. The bottle contains 15 milliliters. The recalled product in the United Kingdom is Vicks Sinex Micromist Aqueous Nasal Spray Solution, and in Germany, Wick Sinex Schnupfenspray Dosiersystem.
The lot number for the nasal spray product is listed on both the outer carton and the bottle. Consumers who have the product should throw it away and contact the company for a replacement coupon or a refund. The contact number in the United States is 1-877-876-7881 and is available Monday through Friday from 9 AM to 6 PM and Saturday and Sunday 9 AM to 4 PM, Eastern Standard Time.
Proctor & Gamble is having the product removed from store shelves and has informed regulatory authorities of the recall. Consumers who believe they have experienced any adverse effects from using Vicks Sinex Nasal Spray should report it via the Food and Drug Administration’s (FDA) MedWatch Program on the MedWatch web site at www.fda.gov/medwatch.
Centers for Disease Control and Prevention
Proctor & Gamble