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FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate
The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin cleanser products containing chlorhexidine gluconate. Chlorhexidine gluconate is a widely used antiseptic. It is mainly available in over-the-counter (OTC) products used to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels. The following products contain chlorhexidine gluconate: --- OTC products are available as topical solutions, washes, sponges, and swabs. They are marketed under brand names such as Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Pharmaseal Scrub Care, and Prevantics. They are also sold as generic products, including store brands. --- Prescription oral rinse solution to treat gingivitis. It is marketed under the brand name Peridex as well as many generic brands such as Periogard, Oris, PerioRx, and Paroex. --- Prescription oral chip under the brand name Periochip, which is inserted between the gums and teeth to treat periodontal disease. --- Some medical devices such as dressings and intravenous lines also contain chlorhexidine gluconate. For more information, please visit: https://www.fda.gov/Drugs/DrugSafety/ucm530975.htm
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Köhler Pharma ruft eine Charge Lophakomp-B12-Depot 1000 µg Injektionslösung zurück
Die Firma Köhler Pharma GmbH ruft eine Charge Lophakomp-B12-Depot 1000 µg Injektionslösung, Packungen mit 5, 10, 20, 50, 100 und 200x2 ml, zurück. Die Charge mit der Bezeichnung 16169 wird zurückgerufen, weil bei Routineuntersuchungen des Herstellers Ergebnisse außerhalb der erlaubten Spezifikation festgestellt wurden. Lophakomp-B12-Depot 1000 µg Injektionslösung enthalten den Wirkstoff Hydroxocobalamin (Vitamin B12) und werden zur Behandlung von Vitamin B12 Mangel verwendet. Dieser Rückruf betrifft nur die genannte Charge Lophakomp-B12-Depot 1000 µg Injektionslösung. Andere Chargen, Stärken oder Formen sowie Vitamin B12-Präparate anderer Hersteller sind von dem Rückruf nicht betroffen. Weitere Informationen unter: http://www.drugbase.de/de/datenbanken/abda-datenbank/aktuelle-infos/artikel.html?tx_ttnews%5Bpointer%5D=4&tx_ttnews%5Btt_news%5D=2177947&tx_ttnews%5BbackPid%5D=115&cHash=98128d4f5afbcae0a2024dfc92244cd1
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Date Published Title Drug Source
2017-07-31 FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate Chlorhexidine FDA
2017-12-17 Köhler Pharma ruft eine Charge Lophakomp-B12-Depot 1000 µg Injektionslösung zurück Vitamin B AMK
2018-01-02 Puren Pharma ruft alle Chargen von Moxonidin-Actavis 0,3 mg und 0,4 mg Filmtabletten zurück Moxonidine AMK
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2012-04-27 Bayer Healthcare Recalls Select Lots of Alka-Seltzer Plus, Severe Sinus Congestion, Allergy & Cough Formula FDA
2008-03-27 Potential increased risk of heart attack Abacavir FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir Sulfate with Lamivudine / Zidovudine FDA
2012-07-25 GlaxoSmithKline Recalls Single Lot of Trizivir Tablets Abacavir Sulfate with Lamivudine / Zidovudine FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir with Lamivudine FDA
2011-03-01 FDA Review of Abacavir Finds No Increased Risk of Heart Attack Abacavir with Lamivudine FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Abobotulinumtoxina FDA
2012-05-15 Forest Pharmaceuticals Inc. Recalls Several Lots of Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg Acamprosate FDA
2008-10-08 Important Information About Safe Use of Children's Cough and Cold Medicine Acetaminophen Manufacturer
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen FDA
2009-06-25 FDA Publishes Question and Answer Guide about Acetaminophen Use Acetaminophen FDA
2009-09-25 Voluntary Recall of Several Children's and Infants' Tylenol Products Acetaminophen Manufacturer
2009-10-23 Recall of Several Acetaminophen Products Acetaminophen FDA
2009-12-29 Voluntary Recall of All Lots of Tylenol Arthritis Pain Caplet 100 Count Bottles Acetaminophen Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen Manufacturer
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