Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers
AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.
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Rare Diseases Team
The Rare Diseases Program facilitates, supports and accelerates the development of drug and biologic products for the benefit of patients with rare disorders -
F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
FEI Number 3038253438
Firm Name F.H. Investments Inc dba Asteria Health
Record Type 483
State AL
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iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)
The goal of the iPLEDGE REMS is to mitigate the risk of embryo-fetal toxicity. -
Questions and Answers on the iPLEDGE REMS
Questions and Answers on the iPLEDGE REMS -
Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers sho -
FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces – 05/29/2025
Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29, 2025. -
Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems
FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monit -
Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System
MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate -
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS -
Electronic Registration and Listing Compliance Program
Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). -
National Drug Code Directory
National Drug Code Directory