FDA bars H&P Industries, Triad Group from manufacturing, distributing OTC products
ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.
Triad Group distributes and H&P Industries manufactures a variety of over-the-counter drug products, including povidone-iodine and benzalkonium chloride antiseptic products, cough-cold products, nasal sprays, suppositories, medicated wipes, antifungal creams and hemorrhoidal wipes.
Under the decree, the defendants cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess.
“This action is necessary to ensure that the companies operate in full compliance with federal quality standards and do not pose a risk to patients,” FDA’s associate commissioner for regulatory affairs Dara Corrigan said.
FDA inspections from 2009 to 2011 determined that H&P failed to comply with the FDA’s good manufacturing practices regulations, which are intended to assure the safety, quality and purity of manufactured drugs. Since December 2010, H&P has initiated five voluntary product recalls, including two because of bacterial contamination of its products.
The FDA’s most recent inspection of H&P, completed on March 28, found multiple cGMP violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications and failure to take appropriate measures to ensure the quality of incoming components.
In April, U.S. marshals, at the request of the FDA, seized more than $6 million in products held at the Triad Group’s and H&P Industries’ Hartland facility. Under the decree, the seized products are condemned and forfeited to the United States. The defendants, after posting a $4 million bond with the court, may seek the FDA’s approval to “recondition” the seized articles. If the defendants’ proposals are unacceptable to the FDA, however, the company is obligated to destroy them at its own expense.
The decree, filed by the Department of Justice’s Office of Consumer Protection Litigation and the U.S. Attorney’s Office for the Eastern District of Wisconsin, will become effective upon entry by the court.
Bayer Advanced Aspirin officially launches
MORRISTOWN, N.J. — Bayer on Tuesday introduced its new Bayer Advanced Aspirin, billed as relieving pain “twice as fast” as the previous Extra Strength Bayer Aspirin.
Using a patent-pending Pro-Release technology, the particles in the new formulation are one-tenth the size of Extra Strength Bayer Aspirin and dissolve six times faster.
As previously reported by Drug Store News, the new aspirin will be positioned as a premium internal analgesic and will be targeted toward younger customers in an effort to grow market share as the company’s Bayer Aspirin (81-mg aspirin) brand is better known as a preventive measure for heart attacks.
Bayer also said it has established a website for healthcare professionals at BayerAspirinPro.com.
Church & Dwight’s Trojan brand releases census on intimacy
PRINCETON, N.J. — New findings released Tuesday as part of the Trojan U.S. Sex Census revealed the average adult has sex 120 times a year (2.3 times per week), with more people in the Northeast reporting having sex more than any other U.S. region, averaging 130 times per year (2.5 times per week).
The Midwest reported an average of 125 times per year (2.4 times per week), the West reported an average of 120 times per year (2.3 times per week) and the South reported an average of 114 times per year (2.1 times per week).
Researchers found residents of metropolitan centers, such as Los Angeles and Houston, are having the most sex per year: 135 times and 125 times, respectively, while residents of Philadelphia and Dallas have the least: 99 and 104 times each, respectively.
In addition, 43% of Northeasterners reported they were more likely to use a condom during sexual activity, the highest rate in the nation.
The Sex Census, commissioned by Church & Dwight, is based on two studies conducted by StrategyOne from March 15 to 21. The first, a national sample of 1,000 10-minute surveys, were conducted online among U.S. adults ages 18 years and older. The second is a study conducted online in 10 major U.S. cities among adults ages 18 years and older. The cities were New York; Los Angeles; Chicago; Philadelphia; Boston; San Francisco; Dallas/Ft. Worth; Washington, D.C.; Atlanta; and Houston. A total of 2,000 10-minute surveys were conducted.