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Tag Archives: Dexilant
BIVIGAM Immune Globulin Intravenous Recall
Translation BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall – Visible Particles Observed AUDIENCE: Risk Manager, Infectious Disease, Health Professional ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Infectious Disease, Risk Manager
Tagged (Human), 10 Percent Liquid, 100 mL, BIVIGAM Immune Globulin Intravenous, BIVIGAM Immune Globulin Intravenous Recall, Dexilant, drug risks, FDA recall, Gastroenterology, Health Professional, Infectious Disease, Recall, Risk Manager, Sterile Vial
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May 2012 Safety Labeling Changes
TranslationThe MedWatch May 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2012, FDA Label Change
Tagged 0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w, 2% Chlorhexidine Gluconate, 4% w/v chlorhexidine gluconate, Aciphex, Actoplus Met, Aredia, Avagard Surgical and Healthcare Personnel Hand Antiseptic, benazepril, Biaxin Filmtabs, Biaxin Granules, Biaxin XL Filmtabs, brand of iopromide, Catapres, Catapres-TTS, CHG, Chlorascrub Swabsticks, chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w, chlorhexidine gluconate 2% and 4%, clarithromycin extended release tablets, clarithromycin for oral suspension, clarithromycin tablets, clonidine, clonidine hydrochloride, Delayed-Release Tablets, Dexilant, dexlansoprazole, dexmethylphenidate hydrochloride, Divigel, Drug Safety Communication, estradiol gel, ethosuximide, FDA notice, Fingolimod, Focalin, Focalin XR, Folotyn, For Delayed-Release Oral Suspension, Gilenya, Hibiclens, Hibistat, Injection Pharmacy Bulk Pack, lansoprazole, Lotensin, May 2012 Safety Labeling Changes, Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets, pamidronate disodium, pantoprazole sodium, pantoprazole sodium For Injection, pioglitazone hydrochloride plus metformin hydrochloride, pralatrexate injection, Prevacid, PRotonix, rabeprazole sodium, safety label changes, Scrub-Stat 2% and Scrub-Stat 4%, Transdermal Therapeutic System, Ultravist, USP), Zarontin
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Proton Pump Inhibitors PPIs Drug Safety Communication
TranslationProton Pump Inhibitors (PPIs) – Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium) Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole) and … Continue reading
Posted in Consumer Products, Family Practice, FDA 2012, FDA Notice, FDA Safety Communication, FDA Warning, Gastroenterology
Tagged Aciphex, Dexilant, drug risks, Drug Safety Communication, FDA notice, FDA Safety Communication, FDA warning, Nexium, Omeprazole, Prevacid, Prilosec, Proton Pump Inhibitors PPIs, Proton Pump Inhibitors PPIs Drug Safety Communication, PRotonix, safety label changes, stomach acid reducers, Vimovo, Zegerid
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MedWatch May 2011 Safety Labeling Changes
TranslationThe MedWatch May 2011 Safety Labeling Changes posting includes 47 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” provides a listing of drug … Continue reading
Posted in FDA 2011, FDA Label Change
Tagged Aciphex, Afinitor, Aldactazide, Avandamet, Avandaryl, Avandia, Benicar HCT, Biaxin Filmtab, Changes, Dexilant, FDA notice, FDA warning, Genotropin, Humalog, Imuran, Labeling, Levatol, MedWatch May 2011, Micardis HCT, Norditropin Cartridges, Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets, Prevacid, Prevacid SoluTab, Prilosec, PRotonix, Purinethol, safety, safety label changes, Seroquel, Sutent, Teveten HCT, Uniretic, Vimovo, Zegerid, Ziac
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Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication – Low Magnesium Levels Can Be Associated With Long-Term Use
TranslationProton Pump Inhibitor drugs (PPIs): Drug Safety Communication – Low Magnesium Levels Can Be Associated With Long-Term Use Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), AcipHex (rabeprazole … Continue reading
Posted in Consumer Products, FDA Notice, FDA Warning
Tagged Aciphex, Adverse Effects, Dexilant, drug risks, FDA notice, FDA warning, Low Magnesium, Nexium, PPIs, Prevacid, Prilosec, Proton Pump Inhibitors, PRotonix, Vimovo, Zegerid
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