US FDA

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Empower Clinic Services LLC dba Empower Pharmacy. Houston, TX. 483 issued 11/14/2025
FEI Number 3021758709
Firm Name Empower Clinic Services LLC dba Empower Pharmacy
Record Type

Sonoma, CA — Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and ot

Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.

This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

FOR IMMEDIATE RELEASE – December 16, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter,

Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys

WHITE PLAINS, N.Y. and LOUISVILLE, Colo., December 15, 2025 – Danone U.S. is voluntarily recalling its So Delicious Dairy Free® Salted Caramel Cluster Non-Dairy Frozen Dessert pints with multiple best-by expiration dates before 08 Aug 2027 at retail stores nationwide due to the potential presence of

This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.