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FDA Medwatch Alert: Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

Posted 7 Dec 2017 by

[Posted 12/05/2017] ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are: SD2070421201 (Exp. 12/2019) SD2070420925 (Exp. 09/2019) SD2070420601 (Exp. 12/2019) The affected lots were distributed between 10/18/2016 and 07/19/2017. The use of impacted Alcohol Prep Pads could result in adverse events such as infections. BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns. RECOMMENDATION: ... Read more

Related support groups: Denatured Alcohol, Butterfly Alcohol Pad, Lavacol, SureComfort, Alcare Plus, Nozin, BD Single Use Swab, Isopropyl Alcohol, Topical Disinfection, BD Butterfly Alcohol Pad

FDA Asks How Safe Is That Hand Sanitizer?

Posted 29 Jun 2016 by

WEDNESDAY, June 29, 2016 – Millions of Americans use hand sanitizers every day, believing they safely kill bacteria. Now, the U.S. Food and Drug Administration wants to find out if that's really true. The agency Wednesday requested makers of antibacterial hand sanitizers and related products to provide data showing the products' active ingredients actually reduce bacteria and are harmless over time. Of particular concern are the long-term effects of these sanitizers on pregnant women and children, the agency said. "These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it's our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and ... Read more

Related support groups: Infections, Benzalkonium Chloride, Ethanol, Dehydrated Alcohol, Denatured Alcohol, First Aid Antiseptic, A + D Cracked Skin Relief, Swim Ear, Ethyl Alcohol, Benza, Benzalkonium Chloride/Pramoxine, Auro-Dri, Herpetrol, BD Single Use Swab, Benzalkonium Chloride/Benzocaine, Mercuroclear, Iodine Povacrylex/isopropyl Alcohol, Butterfly Alcohol Pad, Benzalkonium Chloride/Menthol, Palcohol

How to Prevent Painful Swimmer's Ear

Posted 19 Jun 2016 by

SATURDAY, June 18, 2016 – Swimmer's ear – a common summertime problem among children – is easy to prevent, an expert says. "Swimmer's ear is a bacterial or fungal infection caused by water caught in the ear canal. The tell-tale signs are swelling of the ear canal and some drainage or discharge," said Dr. Nina Shapiro, director of pediatric otolaryngology at Mattel Children's Hospital of the University of California, Los Angeles. Other types of ear infections cause pain inside the ear, but swimmer's ear causes pain when the outside of the ear is touched, Shapiro said in a university news release. Swimmer's ear can be prevented by using the corner of a washcloth or towel to dry ears after swimming. If a hair dryer is available, use the low setting and place the dryer about one foot away from the ear to dry it, Shapiro said. Never use a cotton swab to clean or dry the ear canal because ... Read more

Related support groups: Ear Conditions, Acetic Acid, Otitis Externa, Auralgan, Fem pH, Domeboro Otic, Vosol, Swim Ear, Acetic Acid/Aluminum Acetate, Borofair, Vosol HC, PR Otic, Acid Jelly, Oticot HC, Isopropyl Alcohol, Acute Otitis Externa, Star-Otic, Treagan, BD Butterfly Alcohol Pad, Vasotate

FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics

Posted 30 Apr 2015 by

April 30, 2015 – The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. “Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.” Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing ho ... Read more

Related support groups: Betadine, Betadine Douche, Betadine Mouthwash/Gargle, Summers Eve, Lugols Strong Iodine, Clinidine, Povidine, Lugols Solution, Betadine Surgi-Prep Brush, Povidex Peri, BD Single Use Swab, Iodine Tincture, Betagen, Betadine Aerosol Spray, SureComfort, Pharmadine, Aerodine, Hospital Antiseptic, GRX-Dyne, Betadine Skin Cleanser

FDA Seeks to Improve Safety of Antiseptic Swabs

Posted 14 Nov 2013 by

THURSDAY, Nov. 14 – Manufacturers of antiseptic swabs and solutions are being asked to make voluntary labeling and packaging changes, the U.S. Food and Drug Administration said Thursday. The goal is to improve the products' safety when applied to the skin before surgery or injections. Reports of infections linked to the over-the-counter antiseptics are infrequent but continuing, the agency said in a statement explaining its request. When used properly, these antiseptic swabs and solutions safely reduce the number of bacteria on patients' skin before they undergo an operation or receive shots. But use of contaminated antiseptics has led to localized infections and even death, according to the FDA. "Most often, contamination of [antiseptic products] occurs when organisms are introduced into the product by users," the agency said in the news release. The FDA is asking for labeling changes ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Skin Disinfection, Preoperative, Lugols Solution, Perisol, Denatured Alcohol, Benza, Lugols Strong Iodine, CureChrome, Spectrum-4, BD Single Use Swab, Exidine, Dyna-Hex, Pedi-Pro (Benzalkonium), Topical Disinfection, Hibistat, Isopropyl Alcohol

FDA Medwatch Alert: Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

Posted 13 Nov 2013 by

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.  When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections.  However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.  Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection. Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Lugols Solution, Perisol, Denatured Alcohol, Benza, Lugols Strong Iodine, CureChrome, Spectrum-4, BD Single Use Swab, Exidine, Dyna-Hex, Pedi-Pro (Benzalkonium), Hibistat, Isopropyl Alcohol, Calgon Vesta, PerioChip

Health Tip: Clean a Wound Carefully

Posted 25 Jan 2012 by

-- When you get a cut, scrape or minor puncture wound, careful cleaning can help prevent an infection. The American Academy of Family Physicians offers these suggestions for cleaning a minor wound: Run cool water over the wound, either by pouring from a cup or holding the area under running water. Using a soft washcloth and soap, gently clean the skin. Avoid applying soap directly in the wound. Clean a pair of tweezers with isopropyl alcohol, then use the tweezers to remove any dirt or debris in and around the wound. Avoid using strong cleansing solutions such as hydrogen peroxide or iodine. Use plain water unless otherwise directed by a doctor. Read more

Related support groups: Hydrogen Peroxide, Lugols Solution, Lugols Strong Iodine, Peroxyl, Iodine Mild, SureComfort, Orajel Mouth Sore Rinse, BD Butterfly Alcohol Pad, Perimax Perio Rinse, Butterfly Alcohol Pad, Proxacol, Iodine Tincture, Isopropyl Alcohol, Orajel Perioseptic Rinse, BD Single Use Swab

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