FDA announces voluntary recall of injectables produced by Coastal Meds

FDA
After Coastal Meds didn’t make the recall public at the request of the FDA, the agency issued an alert to health care professionals. (FDA)

The FDA made public a voluntary recall of sterile injectable drugs produced by compounder Coastal Meds of Biloxi, Mississippi, after visible particles were found in some vials.

The company issued a voluntary recall in early April, however, after Coastal Meds didn’t make the recall public at the request of the FDA, the agency issued an alert to health care professionals not to use and to dispose of the products manufactured by Coastal.

During a recent inspection of the company’s facility, investigators found visible particulates and poor sterile production practices, raising concerns about particulates in Coastal’s drug products intended for injection.

Infographic

[Infographic] Machine Learning, Statistics and Optimizing Outcomes

In this infographic, Medidata outlines the potential of fusing machine learning and statistics algorithms together to more efficiently analyze clinical trial data output and ultimately revolutionize clinical research.

To date, there have not been any reports of adverse events associated with drug products produced by Coastal. The company is registered as an outsourcing facility.

Read more on

Suggested Articles

Chinese CDMO GenScript Biotech opened a new biologics clinical supply manufacturing facility even as it is working on a commercial supply facility.

Bayer is recalling two lots of its top-selling drugs after a labeling mishap led to them being filled with the wrong hemophilia medicines. 

Biohaven Pharmaceuticals has been unexpectedly hit by a complete response letter for using an Apotex API.