The Procter & Gamble Company is recalling one lot of its Vicks Sinex nasal spray in the U.S.
The company 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 people 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 is limited to a single batch of raw material mixture. The lot number affected is 9239028831, and the recall applies only to the Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist 15 ml nasal spray product. This lot number is listed on both the outer carton and the bottle.
Consumers should discard the affected product as they would any OTC medicine and then call the company for a replacement coupon or refund at 877-876-7881. Operators are available at this toll-free number Monday through Friday from 9 a.m. until 6 p.m. EST and Saturday and Sunday from 9 a.m. until 4 p.m. EST.
Any adverse events with the use of this product or quality problems should be reported to the FDA's MedWatch Program:
- By fax: 800-FDA-0178
- By postal mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
- Online: www.fda.gov/medwatch
P&G is temporarily removing the product in question from store shelves.
Contact:
Tom Millikin
513-622-1522
millikin.tm@pg.com


