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Monthly Archives: January 2012
Vitaflo USA Renastart Recall
Translation Vitaflo USA Renastart: Recall – Possible Health Risk Due To Incorrectly Labeled Cans AUDIENCE: Pediatrics, Health Professionals, Consumers ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the … Continue reading
Posted in Consumer Products, FDA Recall, Pediatrics
Tagged Consumers, drug risks, FDA recall, Pediatrics, Recall, Renastart, Vitaflo USA, Vitaflo USA Renastart Recall
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Treanda bendamustine HCL Recall
TranslationTreanda (bendamustine HCL): Recall – Particulate Matter in Vial AUDIENCE: Risk Manager, Oncology, Pharmacy ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being … Continue reading
Posted in FDA 2012, FDA Recall, Oncology, Pharmacy, Risk Manager
Tagged bendamustine HCL, Cephalon, chronic lymphocytic leukemia (CLL), drug risks, FDA recall, indolent B-cell non-Hodgkin’s lymphoma (NHL), Oncology, Pharmacy, Recall, Treanda, Treanda bendamustine HCL Recall
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Tysabri (natalizumab) Drug Safety Communication
TranslationTysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Neurology, Gastroenterology ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal … Continue reading
Perfect Image Solutions Topical Hair Regrowth Products Recall
TranslationPerfect Image Solutions Topical Hair Regrowth Products: Recall – Unapproved Drugs, Risk of Health Hazards Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL Men’s Minoxidil 5% Azelaic 5% Hair regrowth … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall
Tagged Consumer Products, drug risks, FDA recall, Hair regrowth topical, Men's Minoxidil, Perfect Image Solutions, Perfect Image Solutions Topical Hair Regrowth Products Recall, Recall, Topical Hair Regrowth Products, unapproved new drugs, Women's Minoxidil
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Vagifresh Ball Vagifresh Gel Female One Recall
TranslationVagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN
Tagged Bacterial Contamination, drug, drug risks, fda, FDA notice, FDA recall, FDA warning, Female One, OBGYN, Recall, Undeclared Drug Ingredient, USA Far Ocean Group Inc, Vagifresh Ball, Vagifresh Ball Vagifresh Gel Female One Recall, Vagifresh Gel
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The Biggest Drug Recalls of 2011
TranslationThe Biggest Drug Recalls of 2011 Always be careful when you take your medications. Make sure you talk about it with your doctor or make some research because some of them may worsen the condition or risk your health instead … Continue reading
Posted in FDA 2011, FDA Recall
Tagged 2011, Class 1 Recall, drug recalls, drug risks, FDA notice, FDA recall, FDA warning, Recall
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Adcetris (brentuximab vedotin) Drug Safety Communication
TranslationAdcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity AUDIENCE: Oncology, Hematology, Neurology ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in … Continue reading
Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology
Tagged Adcetris, Adcetris (brentuximab vedotin) Drug Safety Communication, brentuximab vedotin, drug risks, Drug Safety Communication, FDA notice, FDA warning, Progressive Multifocal Leukoencephalopathy, Pulmonary Toxicity, safety label changes
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December 2011 Safety Labeling Change
TranslationThe MedWatch December 2011 Safety Labeling Changes posting includes 40 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 2011, FDA Label Change, FDA Warning
Tagged Capoten, Danocrine, December 2011, December 2011 Safety Labeling Change, Desferal, Dilantin-125, drugs, Edarbi, Eloxatin, fda, Heparin, Isentress, Keppra, labeling change, Multaq tablets, Norvir, notice, Onglyza, Ovide, PegIntron, Plavix, Relenza, Remeron, safety, Tyzeka, warnings, Zegerid
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Bedford Laboratories Polymyxin B Vecuronium Bromide Recall
TranslationBedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall – Glass Particles AUDIENCE: Pharmacy, Risk Manager ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were … Continue reading
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health
TranslationEndo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk Including the following products: Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII Opana (oxymorphone hydrochloride) CII Oxymorphone hydrochloride Tablets CII PERCOCET (oxycodone hydrochloride and acetaminophen USP) … Continue reading
Posted in Consumer Products, FDA 2011, FDA Warning, Pharmacy
Tagged drug risks, Endo Pharmaceuticals .Opiate Products. Novartis Consumer Health, Endo Pharmaceuticals Opiate Products by Novartis Consumer Health, ENDOCET, ENDODAN, FDA notice, FDA warning, MORPHINE SULFATE, Opana, Opana ER, Oxymorphone, PERCOCET, PERCODAN, ZYDONE
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