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Endo Recalls Clonazepam Due to Mislabeling

[ Price : $8.95]

Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.

FDA Research Links Montelukast to Mental Issues

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FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental...

Counterfeit Batteries Leads to Infusion Pump Recall

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ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devic...

Guide on 510(k) Third-Party Reviews

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Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency...

CDRH New Pilot on High-Risk Recalls

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CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by compa...

IC-Green Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for re...

MXBBB Recalls Umary Hyaluronic Acid Tablets

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FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclofenac and omeprazole.

Over 290 OCI Arrests in FY 2023: FDA

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FDA assistant commissioner Justin Green reports on over 290 arrests last year by the agencys Office of Criminal Investigations.

Burdensome Device Assessment Guidance: Post

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Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as...

Johns Hopkins Surgeon Eyed for FDA Top Job

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News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next ...