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U.S. Department of Health and Human Services

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Recall -- 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.

 

P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom

P&G Media Contacts:

U.S. Media
Tom Millikin, +1.513.622.1522
millikin.tm@pg.com

Paul Fox, +1.513.884.2592
fox.pd@pg.com

U.K. Media
Lee Bansil, + 44.7780.223895
bansil.l@pg.com

German Media
Andrea Riepe, +49.172.302.3253
riepe.a@pg.com

FOR IMMEDIATE RELEASE - Nov. 19, 2009 - Cincinnati - 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.  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

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.

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)

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.

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