IBSPOT.com Inc. – 715657 – 10/27/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Danielle White Recipient Title President IBSPOT.com Inc. 1414 Willow AvenueElkins Park, PA 19027United States support@ibspot.com Issuing Office: Center for Drug Evaluation and Research (CDER) United...

Konrad Rejdak, MD, PhD – 671405

Recipient: Recipient Name Konrad Rejdak, M.D. Konrad Rejdak, MD, PhD Samodzielny Publiczny SzpitalKliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8,20-090 LublinPoland Rejdakk@gmail.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States...

Konrad Rejdak, M.D., Ph.D. – 671405

Delivery Method: UPS and Electronic Mail Reference #: CBER 24-671405 Product: Biologics Recipient: Recipient Name Konrad Rejdak, M.D., Ph.D. Konrad Rejdak, M.D., Ph.D. Kliniczny Nr 4 w Lublinieul. Jaczewskiego 820-090 LublinPoland Issuing Office: Center for Biologics...

PROQUAD

STN: 125108Proper Name: Measles, Mumps, Rubella and Varicella Virus Vaccine LiveTradename: ProQuadManufacturer: Merck Sharpe & Dohme LLCIndication:ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella...

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

Summary Company Announcement Date: November 06, 2025 FDA Publish Date: November 07, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-specification endotoxin results Company Name: Fresenius Kabi USA, LLC Brand Name: Product...