MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25% Zinc Oxide 60g Due to Potential Contamination

FOR IMMEDIATE RELEASE – March 29, 2018 – El Segundo, CA, MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. is voluntarily recalling four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US.

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Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment

The catheter tip can become detached during a patient procedure which could lead to serious injury or death.

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LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue

LeMaitre is recalling the Over the Wire Embolectomy Catheter because of the possibility of difficulty in balloon deflation during use.

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All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

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CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients.

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Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture

Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the device could fracture during use.

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Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b

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Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT)

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Ventilator Supply Mitigation Strategies: Letter to Health Care Providers

Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications

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Medical Glove Conservation Strategies: Letter to Health Care Providers

FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.

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Farmacovigilanza

MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25% Zinc Oxide 60g Due to Potential Contamination

Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment

LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue

All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture

Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

Ventilator Supply Mitigation Strategies: Letter to Health Care Providers

Medical Glove Conservation Strategies: Letter to Health Care Providers

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