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:
||Vicks Sinex VapoSpray 12-Hour Decongestant UltraFine Mist, 15 ml
||Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml
||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: 877-876-7881. (Hours of operation: Monday through Friday, 9 a.m. to 6 p.m. U.S. ET, Saturday and Sunday, 9 a.m. to 4 p.m. U.S. ET)
From the United Kingdom, please call: 0800-5555-15. (Hours of operation: 19 November, 4 p.m. to 9 p.m. local time and will continue Monday through Friday, 8 a.m. to 6 p.m. local time, Saturday and Sunday, 9 a.m. to 5 p.m. local time)
From Germany, please call: 0800-111-6131 (Hours of operation: 19 November, 4 p.m. to 9 p.m. local time and will continue Monday through Friday, 8 a.m. to 6 p.m. local time, Saturday and Sunday, 9 a.m. to 5 p.m. 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 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fisher’s 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®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Gain®, Pringles®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Duracell®, Olay®, Head & Shoulders®, Wella®, Gillette®, Braun®, and Fusion®. 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.
P&G Media Contacts:
U.S. Media Tom Millikin, +1.513.622.1522 firstname.lastname@example.org
Paul Fox, +1.513.884.2592 email@example.com
U.K. Media Lee Bansil, +44.7780.223895 firstname.lastname@example.org
German Media Andrea Riepe, +49.172.302.3253 email@example.com