An Inconvenient Woman » FDA Product Recall http://iconicwoman.com Don’t Get Angry, Get Active! Thu, 19 Jan 2012 09:10:07 +0000 en hourly 1 FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products http://iconicwoman.com/fda-product-recall/fda-issues-warning-letters-to-marketers-of-topical-ibuprofen-drug-products/ http://iconicwoman.com/fda-product-recall/fda-issues-warning-letters-to-marketers-of-topical-ibuprofen-drug-products/#comments Fri, 21 Aug 2009 19:09:44 +0000 H. Sandra Chevalier-Batik http://iconicwoman.com/?p=1506

FDA NEWS RELEASEFor Immediate Release: August 20, 2009
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs’ labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research.

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.

The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm

©2012 An Inconvenient Woman. All Rights Reserved.

. ]]> http://iconicwoman.com/fda-product-recall/fda-issues-warning-letters-to-marketers-of-topical-ibuprofen-drug-products/feed/ 0 FDA Recall of Class I SmartMonitor 2 Infant Apnea Monitor http://iconicwoman.com/fda-product-recall/fda-recall-of-class-i-smartmonitor-2-infant-apnea-monitor/ http://iconicwoman.com/fda-product-recall/fda-recall-of-class-i-smartmonitor-2-infant-apnea-monitor/#comments Mon, 18 May 2009 19:25:41 +0000 H. Sandra Chevalier-Batik http://iconicwoman.com/?p=984 MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003


Audience: Consumers, Pediatricians
Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#SmartMonitor

©2012 An Inconvenient Woman. All Rights Reserved.

. ]]> http://iconicwoman.com/fda-product-recall/fda-recall-of-class-i-smartmonitor-2-infant-apnea-monitor/feed/ 0 Product Recall: Mom’s Check The Kid’s Face Paints http://iconicwoman.com/fda-product-recall/product-recall-moms-check-the-kids-face-paints/ http://iconicwoman.com/fda-product-recall/product-recall-moms-check-the-kids-face-paints/#comments Thu, 14 May 2009 02:07:01 +0000 H. Sandra Chevalier-Batik http://iconicwoman.com/?p=886 horizontal rule

FDA News

FOR IMMEDIATE RELEASE
May 12, 2009

Media Inquiries:
Susan Cruzan, 301-796-4675
Consumer Inquiries:
888-INFO-FDA

FDA Alerts Consumers to Recall of Water-Based Face Paints

Fun Express, Inc. recalls children’s face paint associated with adverse events

The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.

The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory.

The following Face Paints manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China, are being voluntarily recalled by Fun Express Inc., a wholly-owned subsidiary of Oriental Trading Co.:

Item Number

Product Description

Universal Product Code (UPC)
85/2077 Blue Face Paint 8 8760048110 7
85/2078 Purple Face Paint 8 8760048112 1
85/2079 Red Face Paint 8 8760048114 5
85/2080 Orange Face Paint 8 8760048116 9
85/2081 Black Face Paint 8 8760048118 3
85/2082 Green Face Paint 8 8760048120 6

Fun Express Inc. is recalling the face paints from the market and FDA advises consumers to stop use of these products and discard them or return them to the retailer.

The FDA encourages consumers and health care providers to report any adverse events from face paints to the FDA as well as to state and local health authorities.

Adverse events and product quality problems can be reported to FDA’s MedWatch Adverse Event Reporting program:

  • online at www.fda.gov/MedWatch/report.htm
  • by calling 1-800-FDA-1088
  • by returning the postage-paid FDA form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm)
    • by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
    • by fax 1-800-FDA-0178

Photo: Product Label: http://www.cfsan.fda.gov/~dms/cosadv.html

©2012 An Inconvenient Woman. All Rights Reserved.

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