However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions. B cepacia poses little medical risk to healthy individuals.

Procter & Gamble (P&G) had detected this problem during routine quality control at the plant. According to the company's analysis, this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the US, Germany and the UK.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.

P&G has said that it found the bacteria B cepacia in a small amount of product from US lot 9239028831 and is conducting testing on the UK and German lots that have been produced from the same batch of raw material mixture.

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The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.

Firm Press Release: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom.

The lot numbers of the products involved are:

       Lot #        Country               Product Name
    9239028831 United States   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
    9224028833 Germany         Wick Sinex Schnupfenspray Dosiersystem, 15 ml

This lot number is listed on both the outer carton and the bottle. Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call: 1.877.876.7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET)

From the United Kingdom, please call: 0800.5555.15 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

From Germany, please call: 0800.111.6131 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

For U.S. Consumers

Any adverse events with the use of this product and/or quality problems in the United States 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.

About Procter & Gamble

Four billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Gain(R), Pringles(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella(R), Gillette(R), Braun(R) and Fusion(R). The P&G community includes approximately 135,000 employees working in about 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.

SOURCE Procter & Gamble

http://www.pg.com