Printer Friendly

FDA SEIZES SPORICIDEN PRODUCTS; TAKES STEPS TO SEEK RECALL

 FDA SEIZES SPORICIDEN PRODUCTS; TAKES STEPS TO SEEK RECALL
 WASHINGTON, Dec. 13 /PRNewswire/ -- The Food and Drug Administration, the Environmental Protection Agency, the Federal Trade Commission and U.S. Attorney's offices joined forces today in actions to protect the public health from potential hazards associated with the use of Sporiciden Cold Sterilizing Solution, a sterilizing and disinfecting agent manufactured by Sporiciden Company of Rockville, Md.
 FDA announced that the U.S. Attorney's offices in Baltimore, and Nashville, Tenn., are filing seizure actions on behalf of FDA against five Sporiciden products because they are adulterated and misbranded. FDA is also issuing a cease and desist order against two of the products, the first step leading towards a mandatory recall, because they may pose a risk to health.
 FDA's actions were initiated after the firm failed to heed repeated warnings by the agency that the products require clearance from FDA before marketing. Subsequent investigations revealed that the sterilizing solution failed effectiveness tests, lacked FDA clearance for labeling claims and was a danger to health.
 The seized products are located at the firm's headquarters in Rockville; a distribution warehouse, Multi-Modal Freight Systems, in Baltimore; and a contract manufacturing facility, Chem-Mix, Inc., in Jonesborough, Tenn.
 EPA simultaneously ordered Sporicidin to stop selling Sporicidin Cold Sterilizing Solution and asked the firm to voluntarily remove the product from the market. EPA also issued an administrative civil complaint to fine the firm $420,000 for making false and misleading claims about the product's effectiveness. In addition, FTC has asked the federal court in Baltimore to issue a preliminary injunction halting any misrepresentations concerning the effectiveness of any dilution of the product, pending the outcome of administrative proceedings.
 FDA Commissioner David A. Kessler, M.D., said: "Sterilizing and disinfecting agents are supposed to protect patients from contact with harmful microorganisms. We will not tolerate products that would permit the transmission of disease from one patient to another.
 "These products do not work. Doctors, dentists and other health professionals should stop using them," he added.
 EPA Administrator William K. Reilly said: "We are urging health- care providers to use alternative products for sterilizing or high- level disinfecting. Products formulated for the control of infections are a serious concern for health-care providers and for EPA. We are making a renewed effort to ensure products we are required to license for use in sterilizing, disinfecting and sanitizing are efficacious and dependable."
 The Centers for Disease Control in Atlanta said it is not aware of any reports of illness from use of these products. Because the sterilizing solution failed an EPA-required test for potency, there is an increased possibility that instruments would not be adequately disinfected. However, the test used for this product is designed to ensure that it will be capable of killing the most resistant organisms, and failure to pass this test does not mean the product will not kill much more fragile organisms such as the HIV virus, the CDC said.
 Sporicidin Cold Sterilizing Solution is used to sterilize or disinfect certain medical instruments, equipment and fiberoptics used in endoscopic surgery, anesthesiology and respiratory therapy.
 The product is advertised as a sterilant and a high-level disinfectant, but these claims are inconsistent with the results of FDA tests. Therefore, the agency recommends that alternative, legally marketed products be used for sterilizing or disinfecting reusable medical devices. FDA recommends high level disinfection for medical devices, such as flexible fiberoptic endoscopes. Health care providers who desire more information about alternatives may call EPA's National Pesticide Telecommunications Hotline at 800-858-7378.
 FDA issued a regulatory letter to the firm in April 1991 citing poor manufacturing practices and failure to obtain necessary FDA approval prior to marketing. The firm failed to take corrective action and continued to market the products.
 Products covered by the cease and desist order are Sporicidin Cold Sterilizing Solution and Sporicidin-HD. These products, plus Sporicidin Brand Disinfectant Solution, Sporicidin Brand Disinfectant Spray and Sporicidin Disinfectant Towelettes, are involved in the seizure action.
 FDA and EPA are taking joint enforcement actions against Sporicidin Cold Sterilizing Solution because the product is regulated by both agencies. EPA has jurisdiction over all pesticides, which include sterilants and disinfectants, and FDA has jurisdiction over all medical devices and the solutions used to disinfect or sterilize them. FTC has jurisdiction over advertising.
 FDA is one of the Public Health Service's eight agencies within HHS.
 -0- 12/13/91
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, after hours, 301-622-0977/ CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:


MK -- DC007 -- 2402 12/13/91 13:27 EST
COPYRIGHT 1991 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 13, 1991
Words:766
Previous Article:PACIFIC SCIENTIFIC'S BROWER COMMENTS ON MARKET SHARES R&D PLAN AND FINANCIAL STRENGTH
Next Article:COSTA CRUISE LINES ANNOUNCES THE 'EUROLUXE GRAND TOUR' ABOARD THE COSTA CLASSICA
Topics:


Related Articles
/C O R R E C T I O N -- SPORICIDIN/
Schein Pharmaceutical Subsidiary Reaches Consent Agreement; INFeD(R) Distribution and Selected Product Manufacturing at Steris to Resume.
Schein Pharmaceutical Takes Further Steps At Marsam Subsidiary.
Berlex Voluntarily Recalls Ultravist(R) Injection 370 mgI/mL.
Expansion of FDA oversight power sought.
FDA faulted for oversight of foreign medical device and drug makers.
ETHEX Corporation Issues Voluntary Nationwide Recall of Prescription Prenatal and Iron Supplements to Wholesale Level.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters