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Tag Archives: USP)
Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall
Translation Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall – Labeling Issue Identified Read the MedWatch Safety Alert, including links to the Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350275.htm AUDIENCE: Risk Manager, Health Professional, Pharmacy ISSUE: Fenwal has initiated … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Pharmacy, Risk Manager
Tagged (CPD), Anticoagulant Citrate Phosphate Dextrose Solution, Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall, BLOOD-PACK Unit, Dietary Supplements, drug risks, FDA recall, Fenwal, Health Professional, Pharmacy, Recall, Risk Manager, Risk Managers, USP)
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August 2012 Safety Labeling Changes
TranslationThe MedWatch August 2012 Safety Labeling Changes posting includes 53 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 and Lamictal XR, and Mirapex ER, Aplenzin, Artemether/Lumefantrine, atomoxetine hydrochloride, Atrovent HFA, August 2012, August 2012 Safety Labeling Changes, Avelox, Bactrim, Bactrim DS, Bupropion Hydrobromide, Capoten, Captopril, Cladribine, Coartem, Complera, Cyclosporine, Diovan HCT, Disoproxil Fumarate, drug risks, Drug Safety Communication, Edurant, efavirenz, Emtricitabine, Enfuvirtide, Etravirine, Fesoterodine Fumarate, Fuzeon, Intelence, Invega Sustenna, Ipratropium Bromide HFA, Isentress, Lamictal, Lamotrigine, Leustatin, Linagliptin, Lovaza, Lucentis, Maraviroc, Mirapex, Moviprep, Moxifloxacin Hydrochloride, Neoral oral Solution, Neoral Soft Gelatin, Nexavar, Norelgestromin/Ethinyl Estradiol, Omega-3-Acid Ethyl Esters, Optison, Ortho Evra, Oxaliplatin, Paliperidone Palmitrate, Panitumumab, PEG-3350, Perflutren Protein-Type A Microspheres Injectable Suspension, Potassium Chloride, pramipexole dihydrochloride, Raltegravir, Ranibizumab, Revatio, Rilpivirine, safety label changes, Safety Labeling Changes, Sanctura XR, Sandimmune, Selzentry, Sevoflurane, sildenafil, Sodium Ascorbate and Ascorbic Acid, Sodium Chloride, Sodium Sulfate, Sorafenib, Spectinomycin, Strattera, Sulfamethoxazole and Trimethoprim, Sustiva, Tenofovir Diovan, Tenofovir Disoproxil Fumarate, Toviaz, Tradjenta, Trobicin, trospium chloride, Ultane and Ultane NovaPlus, USP), valsartan, valsartan/hydrochlorothiazide, Vectibix, Viread
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Hydromorphone Injection Carpuject Recall
Translation Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume Audience: Risk Manager, Pharmacy Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty recall … Continue reading
Posted in FDA 2012, FDA Recall, Pharmacy, Risk Manager
Tagged (C-II), 1 mL fill in 2.5 mL, 2 mg/mL, Carpuject by Hospira Inc, drug risks, FDA recall, Hydrochloride Injection, Hydromorphone Injection Carpuject, Hydromorphone Injection Carpuject Recall, Pharmacy, Recall, Risk Manager, USP)
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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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April 2012 Safety Labeling Changes
Translation The MedWatch April 2012 Safety Labeling Changes posting includes 43 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 … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Aceon, Advicor, Aliskiren, Aliskiren and Amlodipine, Aliskiren and Hydrochlorothiazide, Aliskiren and Valsartan, Altace, Altoprev, Amlodipine and Hydrochlorothiazide, Amturnide, April 2012, April 2012 Safety Labeling Changes, Atacand, Beyaz, Candesartan Cilexetil, Certolizumab Pegol, Cimzia, Conjugated Estrogens, Denosumab, Drospirenone and Ethinyl Estradiol, Drospirenone and Ethinyl Estradiol and Levomefolate Calcium, Drospirinenone and Ethinyl Estradiol, drug risks, Drug Safety Communication, egerid, Erlotinib, Estradiol, Everolimus, FDA notice, Insulin Detemir [rDNA origin], Itraconazole, Krystexxa, Levaquin, Levemir, Levofloxacin, liraglutide [rDNA], Lovastatin Extended-release, nelfinavir mesylate, Neupro, Niacin Extended-release/Lovastatin, Nutropin, Omeprazole and Sodium Bicarbonate, palivizumab, Pazopanib, Pegloticase, Perindopril Erbumine, Prandimet, Premarin, Ramipril, Repaglinide and Metformin HCL, Rotigotine, safety label changes, Safety Labeling Changes, Safyral, Somatropin [rDNA origin], Sporanox, Sunitinib Malate, Sutent, Synagis, Tarceva, Tekamlo, Tekturna, Tekturna HCT, USP), Vagifem, Valturna, Victoza, Viracept, Votrient, Xgeva, Yasmin, Yaz, Zortress
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Phenylephrine HCl Injection USP 1% 5 mL Vial Recall
TranslationUPDATED 02/23/2012] Phenylephrine HCl Injection, USP, 1% 5 mL Vial, (Lot# 0693) recalled. AUDIENCE: Pharmacy ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels … Continue reading
Posted in Clinics, Emergency Rooms, FDA 2012, Hospitals, Pharmacy
Tagged (Lot# 0693), 1% 5 mL Vial, American Regent, Clinics, drug risks, Emergency Rooms, fda, FDA recall, Home Health Care Agencies, Hospitals, Infusion Centers, Pharmacy, Phenylephrine HCl Injection, Recall, USP)
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August 2011 Safety Labeling Changes
TranslationAugust 2011 Safety Labeling Changes: 44 Medical Product Labels with changes to Prescribing Information The MedWatch August 2011 Safety Labeling Changes posting includes 45 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, … Continue reading
Posted in Consumer Products, FDA 2011, FDA Label Change
Tagged Accolate (zafirlukast) tablets, Actos (pioglitazone hydrochloride) Tablets, and Lamictal XR Extended-Release Tablets, and Oral Solution, August 2011 Safety Labeling Changes, Bentyl (dicyclomine hydrochloride, Betapace and Betapace AF (sotalol HCl) Tablets, BiCNU (carmustine for injection), Celexa (citalopram hydrobromide) Tablets and Oral Solution, Chewable D, DepoCyt (cytarabine liposome injection), Ditropan (Oxybutynin chloride) Tablets, Dostinex (cabergoline) Tablets, Exjade (deferasirox) Tablets for Oral Suspension, Haldol (haloperidol) Injection and Haldol Decanoate (haloperidol) IM Injection, Hyzaar (losartan/hydrochlorothiazide) Tablets, ispersible Tablets Lamictal Orally Disintegrating Tablets, Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets, Kerlone (betaxolol hydrochloride) Tablets, Lamictal (lamotrigine) Tablets, Mobic (meloxicam) Tablets and Oral Suspension, Multaq (dronedarone hydrochloride) Tablets, Neurontin (gabapentin) Capsules, Oral Syrup and Injection, Platinol (cisplatin for injection, Prinzide (lisinopril/hydrochlorothiazide) Tablets, Reclast (zoledronic acid) Injection, Saphris (asenapine) Sublingual Tablets, Sensipar (cinacalcet) Tablets, tablets, Tenoretic (atenolol/chlorthalidone) Tablets, Tenormin (atenolol) Tablets, Thallous Chloride [Tl-201] Injection, USP), USP) Capsules/Tablets, Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate
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