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June 5, 2020

Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein

Summary Company Announcement Date: February 25, 2019 FDA Publish Date: February 25, 2019 Product Type: Dietary SupplementsDrugsNutritional Supplement Reason for Announcement: Recall Reason Description Mislabeling Company […]
June 5, 2020

Completed PDUFA VI Deliverables

2018 Public Meeting on Electronic Submissions and Data Standards Public Meeting Annual meeting to solicit stakeholder input regarding the electronic submission system. Enhance Transparency and Accountability […]
June 5, 2020

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of […]
June 5, 2020

Drug Trials Snapshots: ARTESUNATE

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
June 5, 2020

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of […]
June 5, 2020

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Summary Company Announcement Date: September 28, 2018 FDA Publish Date: May 02, 2019 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Incorrect Daily Dosing […]
June 5, 2020

Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia

Summary Company Announcement Date: August 30, 2017 FDA Publish Date: February 08, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Burkholderia Cepacia Company […]
June 4, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020

For Immediate Release: June 04, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 4, 2020

FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

For Immediate Release: June 04, 2020 Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia […]
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