The Knowledge Shelf

Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.

The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/28/2025
Short Title (70 char) RC Outsourcing, LLC. Lowellville, OH. 483 issued 08/28/2025
FEI Number 3011967886
Firm Name RC Outsourcing LLC
Record Type 483
State OH
Establishment Type Outsourcing Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/22/2025
Short Title (70 char) Nephron Sc Inc. West Columbia, SC. 483 issued 08/22/2025
FEI Number 3010892830
Firm Name Nephron Sc Inc
Record Type 483
State SC
Establishment Type Sterile Drug Manufacturing

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

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures

Malaria: Developing Drugs for Treatment

Cohance Lifesciences Limited – 8/12/2025. Country: India. Record Type: 483

September 20, 2025, Western United Fish Company dba Annasea Foods Group of Kent, WA is recalling 3,314.7 lbs. of Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco Item Number of 17193, with the Sell By Date of 9/22/2025, because the green onions used in the product have the potential to be cont

FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars.