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Monthly Archives: February 2012
Flight Medical V240040029 Cable for Newport HT50 Ventilator Class I Recall
Translation Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly ISSUE: The recalled cable may cause an electrical shortage that can cause Newport … Continue reading
Statin Drugs Drug Safety Communication Class Labeling Change
TranslationStatin Drugs – Drug Safety Communication: Class Labeling Change AUDIENCE: Cardiology, Family Practice, Patients ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver … Continue reading
Posted in Cardiology, Family Practice, FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Advicor, Altoprev, Cardiology, cholesterol-lowering drugs, Class Labeling Change, Crestor, drug risks, Drug Safety Communication, Family Practice, FDA notice, labeling change, LDL, Lescol, Lipitor, Livalo, Mevacor, PRavachol, safety label changes, Simcor, Statin Drugs, Vytorin, Zocor
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Norgestimate and Ethinyl Estradiol Tablets Recall
TranslationNorgestimate and Ethinyl Estradiol Tablets: Recall – Packaging Error, Potential for Incorrect Dosing Regimen AUDIENCE: OB/GYN, Pharmacy, Patient ISSUE: Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 … Continue reading
Posted in OBGYN, Pharmacy
Tagged Birth Control Pills, Dietary Supplements, drug risks, Ethinyl Estradiol Tablets, Family Practice, FDA recall, Norgestimate, Norgestimate and Ethinyl Estradiol Tablets Recall, OBGYN, Oral Contraceptives, Packaging Error, Patient, Pharmacy, Recall
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Cytarabine for Injection 1 gm vial Bedford Labs Recall
Translation Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The … Continue reading
Posted in Clinics, Emergency Rooms, Family Practice, FDA 2012, FDA Recall
Tagged 1 gm vial, Bedford Labs, Clinics, Cytarabine for Injection, Cytarabine for Injection 1 gm vial Bedford Labs Recall, drug risks, Emergency Rooms, Family Practice, FDA recall, Hospitals, Pharmacy, physician offices, Recall
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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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Infants TYLENOL Oral Suspension 1 oz Grape Recall
TranslationInfants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall – Dosing System Complaints AUDIENCE: Consumer, Pharmacy ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Pharmacy
Tagged 1 oz Grape, Consumer, Dosing System Complaints, drug risks, FDA recall, Infants TYLENOL, Infants TYLENOL Oral Suspension 1 oz Grape Recall, McNeil Consumer Healthcare, Oral Suspension, Pharmacy, Recall, SimpleMeasure dosing system
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Avastin bevacizumab Counterfeit Product
TranslationAvastin (bevacizumab): Counterfeit Product – FDA Issues Letters to 19 Medical Practices AUDIENCE: Oncology, Pharmacy, Patient ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by … Continue reading
Posted in FDA 2012, FDA Warning, Oncology, Pharmacy
Tagged Avastin, Avastin bevacizumab Counterfeit Product, bevacizumab, Cancer Drugs, Counterfeit Product, drug risks, FDA warning, Genetech, Montana Health Care Solutions, Oncology, Pharmacy, Quality Specialty Products, Roche
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Wholistic Herbs Inc Koff and Kold Kold Sore Spray Recall
TranslationWholistic Herbs, Inc. “Koff and Kold” and “Kold Sore” Spray: Recall – Non-Sterile Products AUDIENCE: Consumer ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of “Koff & Kold” spray with herbal extract and “Kold Sore” spray … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall
Tagged cold remedy, Dietary Supplements, drug, drug risks, FDA recall, Koff and Kold, Kold Sore Spray, Over the counter, Recall, Wholistic Herbs Inc, Wholistic Herbs Inc Koff and Kold Kold Sore Spray Recall
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Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs Drug Safety Communication
TranslationVictrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions AUDIENCE: Infectious Disease, Pharmacy ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis … Continue reading
Posted in FDA 2012, FDA Notice, FDA Safety Communication, Infectious Disease, Pharmacy
Tagged drug risks, Drug Safety Communication, FDA notice, FDA warning, Human Immunodeficiency Virus (HIV), Protease Inhibitor Drugs, Victrelis (boceprevir) and Ritonavir-Boosted, Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs
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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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