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April 2, 2021

Natural Adventure, LLC – 612267 – 04/01/2021

Product: Drugs Recipient: Recipient Name Jennifer Orejobi Natural Adventure, LLC 13765 SW 32nd StreetMiramar, FL 33027United States [email protected] Date:               April 1, 2021 RE:                  Unapproved and […]
April 1, 2021

2016 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

2016 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee | FDA In this section: Endocrinologic and Metabolic Drugs Advisory Committee Home Advisory Committees Committees and Meeting […]
April 1, 2021

2017 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

2017 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee | FDA In this section: Endocrinologic and Metabolic Drugs Advisory Committee Home Advisory Committees Committees and Meeting […]
April 1, 2021

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Summary Company Announcement Date: December 05, 2018 FDA Publish Date: March 11, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Due to […]
April 1, 2021

FDA and Health Canada Regional ICH Consultation – 05/14/2021 – 05/14/2021

On This Page Date: May 14, 2021 Time: 1:00 PM – 4:00 PM ET FDA and Health Canada will be co-hosting a regional public meeting to […]
April 1, 2021

FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs – 05/05/2021 – 05/05/2021

On This Page Date: May 5, 2021 Time: 9:00 AM – 12:30 PM ET This webinar is FREE. FDA will provide an overview of Product-Specific Guidances (PSGs), […]
March 31, 2021

Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine Fumarate

Summary Company Announcement Date: March 31, 2021 FDA Publish Date: March 31, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Trace amounts of Quetiapine […]
March 31, 2021

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Summary Company Announcement Date: August 28, 2018 FDA Publish Date: March 19, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Microbial Contamination […]
March 31, 2021

Lamictal (lamotrigine): Drug Safety Communication – Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease

[Posted 03/31/2021]  AUDIENCE: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry  ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called […]
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