FDA In Brief: FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/13/2025
Short Title (70 char) Pharmcore Inc. dba Hallandale Pharmacy. Fort Lauderdale, FL. 483 issued 06/13/2025
FEI Number 3014480778
Firm Name Pharmcore Inc. dba Hallandale Pharmacy
Record Type 483
State FL

SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Genzyme Ireland Limited – 01/17/2025. Country: Ireland. Record Type: 483

CGMP/Finished Pharmaceuticals/Adulterated

The Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence is established to facilitate and coordinate the continuous evolution and consistent application of quantitative medicine for drug development and regulatory decision-making across CDER.