Single lot of Sinex VapoSpray recalled
Potential bacterial contamination cited.
Procter & Gamble has recalled lot number 9239028831 of Sinex
VapoSpray 12-hour Decongestant Ultra Fine Mist Nasal Spray 15 ml . At a
German plant, bacterial contamination was found in this product, and
while no adverse events have been reported, the recall was initiated as
a precaution.
The organism involved is the gram-negative bacterium Burkholderia
cepacia (B. cepacia), which was identified in a small amount of product
during a routine quality check at a plant in Gross Gerau, Germany. While
B. cepacia poses little medical risk to healthy individuals, the
bacteria could cause serious infections for patients with compromised
immune systems or those with chronic lung conditions, such as cystic
fibrosis.
The company’s analysis to date shows this problem is limited to
a single batch of raw material mixture involving three lots of product.
The lot mentioned in this article was sold in the United States; the
other two lots were sold in Germany and the United Kingdom. To date,
there have been no reports of illnesses resulting from the tainted
lot.
Pharmacists should instruct patients to discard the product just as
they would any OTC medicine rather than to return it to a store or to a
pharmacy. Pharmacists are also advised to remove any product from the
affected lot from shelves.
Procter & Gamble has established two toll-free phone numbers to
handle all communications related to the recall. Patients with questions
or who wish to receive a replacement coupon or refund should call
1-877-876-7881. Health care professionals should call 1-800-873-8276.
Adverse events and quality problems related to the use of this product
and/or quality problems can be reported via FDA’s MedWatch Program
by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers
Lane, Rockville, MD, 20852; or on the MedWatch Website.
Information about the recall is also available at www.vicks.com.
Beth Farnstrom (bfarnstrom@aphanet.org)
Posted November 20, 2009
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