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July 13, 2022

Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible […]
July 13, 2022

Expanded Access (Compassionate Use) Submission Data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2016-2020) On this page you will find: The Center for Drug Evaluation and Research (CDER) and the […]
July 13, 2022

Mitigating Risks of Compounded Drugs Through Surveillance

FDA’s Compounding Incidents Program aims to help protect the public against poor quality compounded drugs through surveillance and review of complaints, which include adverse event and […]
July 13, 2022

Meeting Presentations | Drugs

CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users […]
July 12, 2022

Caution Consumers:

Image Don’t Fall for False Claims When you’re browsing, one of the best ways to protect yourself from fake, and even possibly harmful, products is asking […]
July 12, 2022

Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. – 609658 – 06/27/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Francisco Cervantes Recipient Title Chief Executive Officer Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. Privada […]
July 12, 2022

Elite Supplement Center LLC and Elite Training Facility LLC – 627498 – 07/06/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER July 6, 2022 Elite Training Facility […]
July 12, 2022

DDI Multinacional S.A. de C.V. – 608864 – 06/27/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Angelica Flores Recipient Title Chief Executive Officer DDI Multinacional S.A. de C.V. Javier Espinoza No. Mz. […]
July 12, 2022

1am USA Incorporated dba Pleasure Products USA – 627006 – 07/01/2022

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]
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