CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing FacilityInfusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramAnazaoHealth Corporation. Las Vegas, NV. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) AnazaoHealth Corporation. Las Vegas, NV. 483 issued 08/08/2025
FEI Number 3011152407
Firm Name AnazaoHealth Corporation
Record Type 483
State NV
Establishment Type Outsourcing FaLunds & Byerlys Voluntary Recalls L&B Monster Cookies Due to Incorrect Labeling
EDINA, Minn., December 9, 2025 – Lunds & Byerlys is voluntarily recalling its L&B Monster Cookies as the wrong ingredient label was applied to the packaging. Packages may contain undeclared peanuts, egg, and soy. People who have allergies to peanuts, egg, and soy run the