Misrepresented hand-sanitizing gel seized by federal government
ROCKVILLE, Md. The Food and Drug Administration ordered the seizure of $230,000 in hand-sanitizing gel last week, the agency announced Friday.
The hand sanitizer, made by Puerto Rico Beverage and distributed by Lord Pharmaceutical/Bee International Distributors, currently is only available for sale in Puerto Rico. The product, which contains benzalkonium chloride, is not approved for sale in the U.S. market, the FDA stated.
The gel was marketed as a product that could kill 99.99% of viruses, bacteria and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.
“The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA,” stated Michael Chappell, FDA acting associate commissioner for regulatory affairs. “Thus, this product is an unapproved new drug and violates federal law. … This seizure action helps ensure that no consumers are harmed by this product.”
The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.
Moreover, the product, which is not labeled correctly, is misbranded under the law because its packaging does not list all inactive ingredients, and its label fails to contain the place of business of the manufacturer, packer or distributor.
The FDA inspected the product manufacturing facility between Aug. 19 and Sept. 28, 2009, and found numerous violations of U.S. current Good Manufacturing Practice requirements, including failure to have a Quality Control Unit; failure to maintain a clean and sanitary processing, packing and holding area; failure to conduct appropriate lab tests and many other violations.
Following that inspection, the firm agreed to recall and destroy its products but has failed to follow through on its commitments. This failure on behalf of the company led the government to request a seizure of the products.
On March 3, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.
McNeil’s recall widens as ‘precautionary measure’
FORT WASHINGTON, Pa. McNeil Consumer Healthcare on Thursday issued yet another recall of 21 lots of over-the-counter medicines. This action is a follow-up to a product recall that McNeil originally announced on Jan. 15, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
Between Jan. 15 and July 8, McNeil has made seven recall announcements, not all because of the TBA chemical, however. The latest lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the Jan. 15 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet.
McNeil has created a website, McNeilProductRecall.com/index.jhtml, that outlines all products affected from each of the recalls.
FDA issues warning about Que She weight-loss supplement
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal weight-loss supplement, actually is an adulterated drug product as it contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.
People who have purchased Que She should stop taking the product immediately and consult a healthcare professional.
Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on such Internet sites as the Bouncing Bear Botanicals website, and at such retail outlets as Sacred Journey in Lawrence, Kan.
An FDA analysis of Que She found that it contained fenfluramine, a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage; propranolol, a prescription beta-blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions; sibutramine, a controlled substance and prescription weight-loss drug, which was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease; and ephedrine, a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.
These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.
Consumers and healthcare professionals are encouraged to report adverse events related to the use of Que She to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: online at FDA.gov/MedWatch/report.htm; by phone at (800) FDA-1088, or (800) 332-1088; or, by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at (800) FDA-0178.