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May 19, 2020

Hieber’s Pharmacy – 542220 – 05/01/2020

Product: Drugs Recipient: Recipient Name Ms. Rosemary E. Mihalko, RPh Recipient Title Owner Hieber’s Pharmacy 3500 5th AvenuePittsburgh, PA 15213-3337United States Issuing Office: Office of Pharmaceutical […]
May 19, 2020

COVID-19 Real World Data (RWD) Data Elements Harmonization Project

Introduction This project aims to harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and open standards.  These data elements have been […]
May 19, 2020

Division of Applied Regulatory Science

The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and develops and implements new regulatory review […]
May 19, 2020

Division of Applied Regulatory Science – A Sampling of DARS Projects

Evaluation of Sunscreen Active Ingredients DARS has conducted two randomized clinical trials which demonstrated systemic exposure of multiple commonly used sunscreen active ingredients under single and […]
May 19, 2020

Kumar Organic Products Limited – 598683 – 04/23/2020

Delivery Method: VIA UPS Reference #: 320-20-34 Product: Drugs Recipient: Recipient Name Mr. K. K. Singh Recipient Title Chairman Kumar Organic Products Limited Plot No. 379 […]
May 19, 2020

C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength

Summary Company Announcement Date: April 21, 2017 FDA Publish Date: February 08, 2018 Product Type: Animal & VeterinaryDrugs Reason for Announcement: Recall Reason Description Due to […]
May 19, 2020

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, Due to Presence White Particulate Matter that has been Identified as Mold

Summary Company Announcement Date: December 21, 2017 FDA Publish Date: December 29, 2017 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description White particulate matter […]
May 19, 2020

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial

Summary Company Announcement Date: December 19, 2017 FDA Publish Date: December 29, 2017 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Contains glass particles […]
May 19, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL

Summary Company Announcement Date: November 02, 2017 FDA Publish Date: December 29, 2017 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled Company Name: Fresenius […]
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