Field Safety Notices: 4 to 8 August 2025
List of Field Safety Notices from 4 to 8 August 2025.
-
-
BSO, LLC. Golden, CO. 483 issued 06/27/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/27/2025
Short Title (70 char) BSO, LLC. Golden, CO. 483 issued 06/27/2025
FEI Number 3030548360
Firm Name BSO, LLC
Record Type 483
State CO
Establishment Type Outsourcing Facility -
Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res -
GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p -
Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. -
Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death -
Project Orbis
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
-
Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach – 09/10/2025
The webinar will feature presentations by Dr. Pippa Curtis-Jackson, Senior Specialist at the Chemical Assessment Unit, UK EA, and Dr. Michelle Embry, Deputy Director of HESI. -
Health Institution Exemption – Stakeholder survey
The MHRA invites health institutions in Great Britain to share their experience of the health institution exemption (sometimes referred to as an in-house manufacturing exemption).
-
Consultation on the Revised International Council for Harmonisation Guideline M4Q(R2)
The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).
-
PDUFA Performance Reports
PDUFA Performance Reports -
Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
FEI Number 3010589333
Firm Name Right Value Drug Stores, LLC
Record Type 483
State TX
Establishment Type Outsourci