Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act
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Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mgMolecular PharmaGroup LLC. New Providence, NJ. 483 issued 08/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/11/2025
Short Title (70 char) Molecular PharmaGroup LLC. New Providence, NJ. 483 issued 08/11/2025
FEI Number 3014413265
Firm Name Molecular PharmaGroup LLC
Record Type 483
State NJ
Establishment Type OutsourWhat You Should Know about Eye Drops
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.BsUFA III: Fiscal Years 2023-2027
New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.SKNV. Pompano Beach, FL. Untitled Letter issued 09/16/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/16/2025
Short Title (70 char) SKNV. Pompano Beach, FL. Untitled Letter issued 09/16/2025
FEI Number 3012384835
Firm Name SKNV
Record Type Untitled Letter
State FL
Establishment Type Outsourcing FacilityFDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
