Recall of Vicks Sinex Nasal Spray

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P & G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United

States, Germany and the United Kingdom

 

FOR IMMEDIATE RELEASE - Nov. 19, 2009 - Cincinnati - The Procter & Gamble

Company 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)

 

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.