November 20, 2009

A voluntary recall has been issued by Procter & Gamble for three lots of Vicks Sinex nasal spray. The recall affects three countries – the United States, Germany and the United Kingdom.

The recall is a result of the discovery of the bacteria B. cepacia in some product made in a Germany plant. So far, there have been no reports of illnesses.

The bacteria could cause serious infections for people who have a compromised immune system or for those with chronic lung conditions such as cystic fibrosis. The release states that B. cepacia poses little medical risk to healthy individuals.

The problem was found during a routine quality control and action was immediately taken. The problem is limited to a single batch of raw material mixture used in three lots of the product.

P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831.

The lot numbers of the products involved are 9239028831 (U.S.) Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray; 9224028832 (United Kingdom) Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml; and 9224028833 (Germany) Wick Sinex Schnupfenspray Dosiersystem, 15 ml.

The lot number is listed on both the outer carton and the bottle. Consumers are told to discard the affected product as they would any OTC medicine.

The product is being removed from store shelves. If you have any of the specific lots call P&G for a replacement coupon or refund at 877-876-7881, Monday through Friday, 9:00 a.m. until 6:00 p.m. ET or Saturday and Sunday from 9:00 a.m. until 4:00 p.m. ET.

Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.