US FDA

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

Lonza Guangzhou Pharmaceutical Ltd. | 10/31/25 | 483

This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.

Dr. Reddy’s Laboratories Limited | 12/12/2025 | 483

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/24/2020
Short Title (70 char) Bruce G. Rankin, DO. DeLand, FL. EIR issued 11/24/2020
FEI Number 3006528394
Firm Name Bruce G. Rankin, DO
Record Type EIR
State FL
Establishment Type Clinical Investigations

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/23/2020
Short Title (70 char) Frank Steven Eder, MD. Binghamton NY. EIR issued 11/23/2020
FEI Number 3006983127
Firm Name Frank Steven Eder, MD
Record Type EIR
State FL
Establishment Type Clinical Investigat

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/23/2020
Short Title (70 char) Steven H. Reynolds, DO. Long Beach, CA. EIR issued 11/23/2020
FEI Number 3017483836
Firm Name Steven H. Reynolds, DO
Record Type EIR
State CA
Establishment Type Clinical Investig

Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions. 

Drug Trials Snapshots: VIZZ

Drug Trials Snapshots: LYNKUET

FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.