January 28, 2021

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling

Summary Company Announcement Date: January 27, 2021 FDA Publish Date: January 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Meitheal […]
January 27, 2021

Office of Prescription Drug Promotion (OPDP) Metrics

Number of core initial promotional campaign material reviews completed in the month Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals […]
January 27, 2021

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin Due to Possible Microbial Contamination

Summary Company Announcement Date: August 29, 2018 FDA Publish Date: March 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Possible Microbial […]
January 27, 2021

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Summary Company Announcement Date: March 15, 2019 FDA Publish Date: March 15, 2019 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Presence of […]
January 27, 2021

Is it legal for me to personally import drugs?

En Español In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other […]
January 27, 2021

FDA in Brief: FDA warns company for putting consumers at risk through distribution of non-compliant and misbranded drug ingredients

January 27, 2021 Media Inquiries   Jeremy Kahn  301-796-8671 The following quote is attributed to Director of the Office of Compliance in the FDA’s Center for Drug […]
January 27, 2021

FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1106-0002 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]
January 27, 2021

Professional Compounding Centers of America dba PCCA – 597638 – 01/27/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Fabian V. Zaccardo Recipient Title Chief Operating Officer Professional Compounding Centers of America dba PCCA […]
January 27, 2021

FDA Updates and Press Announcements on Nitrosamines in Rifampin and Rifapentine

[8/26/2020] These are antibacterial drugs used to treat tuberculosis; rifampin is also used to treat or prevent other serious infections. Patients taking rifampin or rifapentine should […]
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