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Monthly Archives: May 2012
Teva’s Adderall 30 mg Tablets Counterfeit Product
Translation Teva’s Adderall 30 mg Tablets: Counterfeit Product – Contains Wrong Active Ingredients AUDIENCE: Consumer, Health Professional ISSUE: FDA is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is … Continue reading
Baxa Corporation Abacus Total Parenteral Nutrition TPN Calculation Software Class I Recall
TranslationBaxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall – Potential Dosing Errors AUDIENCE: Pharmacy, Risk Manager ISSUE: A number of errors have been reported by Abacus software users as a result of ordering salt based parenteral … Continue reading
Posted in FDA 2012, FDA Recall, Pharmacy, Risk Manager
Tagged Baxa Corporation, Baxa Corporation Abacus Total Parenteral Nutrition, Baxa Corporation Abacus Total Parenteral Nutrition TPN Calculation Software Class I Recall, Calculation Software, Class 1 Recall, Class I Recall, drug risks, FDA recall, Pharmacy, Recall, Risk Manager, TPN
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Dialysate Concentrates Used in Hemodialysis Safety Communication
TranslationDialysate Concentrates Used in Hemodialysis: Safety Communication – Alkali Dosing Errors AUDIENCE: Nephrology, Nursing ISSUE: FDA is notifying health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ … Continue reading
Zithromax azithromycin FDA Drug Risks
TranslationZithromax (azithromycin): FDA Statement on risk of cardiovascular death Read the MedWatch safety alert, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Audience: Primary Care, Pharmacy ISSUE: FDA notified healthcare professionals that it is aware of the study … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, Pharmacy
Tagged azithromycin, FDA Drug Risks, Zithromax, Zithromax azithromycin FDA Drug Risks
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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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Hydromorphone Hydrochloride Injection 1 MG ML Recall
TranslationHospira Carpuject Pre-filled Cartridges – Drug Alert: Products May Contain More Than the Intended Fill Volume CORRECTED NOTICE AUDIENCE: Risk Manager, Health Professional ISSUE: FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured … Continue reading
Franck’s Lab Brilliant Blue Recall
TranslationFranck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall 5/24/2012 AUDIENCE: Ophthalmology, Urology, Primary Care, Pharmacy ISSUE: FDA is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by … Continue reading
Posted in FDA 2012, FDA Recall, Ophthalmology, Risk Manager
Tagged drug risks, FDA recall, FDA warning, Franck’s Lab Brilliant Blue Recall, Recall, Risk Manager
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