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Food & drugs

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Statement - FDA Alerts Patients and Health Care Professionals About

02-06-2020

FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

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Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Dev

02-06-2020

FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

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The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to

01-06-2020

FDA announces BIOCELL Textured Surface Allergan Breast Implants and Tissue Expanders Will No Longer Be Sold in the U.S.

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2020 Medical Device Recalls

01-06-2020

List of Medical Device recalls in 2020.

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Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures

01-06-2020

StealthStation auto-registration feature helps guide surgeons to conduct deep brain stimulation (DBS) procedures. A software issue may lead surgeons to erroneously perform DBS procedures.

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Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg

01-06-2020

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that...

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Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall

01-06-2020

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders...

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Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg

29-05-2020

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that...

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CHS Nutrition Recalls Champion Meat Goat Pellets R20, Medicated Feed, Because of Possible Rumensin (monensin) Health Risk

29-05-2020

PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin). Monensin is an FDA-approved drug for use in...

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2020 Medical Device Recalls

28-05-2020

List of Medical Device recalls in 2020.

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Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set

28-05-2020

These devices are parts of the The HeartWare Ventricular Assist System (HVAD). They attach to the HeartWare HVAD pump which helps the heart deliver blood to the rest of the body. The clamp screws are at risk of breaking when tightening the strain...

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Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection

28-05-2020

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride...

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Food & drugs

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

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