Tag Archives: fda

OxyElite Pro Health Advisory

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translation servicesTranslate | French translation Spanish translation translate German translate Chinese OxyElite Pro: Health Advisory – Acute Hepatitis Illness Cases Linked To Product Use AUDIENCE: Health Professional, Consumer ISSUE: The FDA, along with the Centers for Disease Control and Prevention … Continue reading

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Posted in Consumer Products, FDA 2013, FDA Warning, Healthcare Professionals | Tagged , , , , , , , , | Comments Off

Emergency Cricothyrotomy Kit By H H Medical Corporation Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseEmergency Cricothyrotomy Kit By H&H Medical Corporation: Recall – Defective Cuff Balloon On Endotracheal Airway AUDIENCE: Health Professional, Risk Manager, Critical Care ISSUE: On August 27, 2013, H&H Medical Corporation … Continue reading

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Posted in Critical Care Medicine, FDA 2013, FDA Recall, Healthcare Professionals, Risk Manager | Tagged , , , , , , , , , | Comments Off

Arzerra ofatumumab and Rituxan rituximab Drug Safety Communication

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseArzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication – New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation AUDIENCE: Oncology, Pharmacy, Rheumatology, Patient ISSUE: FDA approved changes to … Continue reading

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Posted in FDA 2013, FDA Safety Communication, Oncology, Patients, Pharmacy, Rheumatology | Tagged , , , , , , , , , , , , , , | Comments Off

April 2013 Safety Labeling Changes

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseThe MedWatch April 2013 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. … Continue reading

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Aliskiren containing Medications Drug Safety Comunication

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseAliskiren-containing Medications: Drug Safety Comunication – New Warning and Contraindication including: Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide) Tekturna (aliskiren hemifumarate) Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tekamlo (aliskiren hemifumarate … Continue reading

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Posted in Endocrinology, FDA 2012, FDA Safety Communication, Internal Medicine, Pharmacy | Tagged , , , , , , , , , , , , , , , , | Comments Off

FDA March 2012 Safety Labeling Changes

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseThe MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The … Continue reading

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Posted in FDA 2012, FDA Label Change, FDA Safety Communication | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Acclarent Inspira AIR Balloon Dilation System Class 1 Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseAcclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly AUDIENCE: Emergency Medicine, Risk Managers ISSUE: Acclarent received four … Continue reading

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Posted in Emergency Rooms, FDA 2012, FDA Recall, Risk Manager | Tagged , , , , , , , , , | Comments Off

Phenylephrine HCl Injection USP 1% 5 mL Vial Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseUPDATED 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 … Continue reading

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Posted in Clinics, Emergency Rooms, FDA 2012, Hospitals, Pharmacy | Tagged , , , , , , , , , , , , , , | Comments Off

Vagifresh Ball Vagifresh Gel Female One Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseVagifresh 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 … Continue reading

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Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN | Tagged , , , , , , , , , , , , , , | Comments Off

December 2011 Safety Labeling Change

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseThe 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. … Continue reading

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Posted in FDA 2011, FDA Label Change, FDA Warning | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off