Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

FDA Alerts Healthcare Professionals To Voluntary Recall Of Sterile Products

By The U.S. Food and Drug Administration | April 16, 2018

The FDA is alerting healthcare professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds LLC, of Biloxi, Mississippi, due to visible particles in some of the drug vials for injection.  

Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions. Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients.

Healthcare professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

During FDA’s recent inspection of Coastal Meds investigators observed visible particulates and poor sterile production practices, which further raise concerns about particulates in Coastal Meds’ drug products intended for injection. 

On April 5, 2018, Coastal Meds initiated a voluntarily recall of all products intended to be sterile. FDA requested the compounder inform the public, but they have not done so. Therefore, FDA is alerting health care professionals to dispose of and not administer sterile drug products intended for injection that were produced and distributed by Coastal Meds. 

To date, FDA is not aware of any reports of adverse events associated with drug products produced by Coastal Meds. 

(Source: The U.S. Food and Drug Association)

Related Articles Read More >

kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
Disposable syringe and American currency on black background
PBMs increasingly under fire in drug-pricing battle
Johnson & Johnson logo
Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact
pharmaceutical industry. Production line machine conveyor with glass bottles ampoules at factory
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE