Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection–Virtual Public Workshop – 05/07/2024

KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.

The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN GOLD 60000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

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.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing Facility

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Personal Importation