Over the past 12 months Caraco has had numerous issues with the US Food and Drug Administration (FDA), with voluntary recalls being followed by a warning letter and the seizure of products.
The consent decree is intended to be a plan that will allow Caraco to resume manufacturing and distributing products form is facilities around Detroit, Michigan, US.
Under the terms of the agreement Caraco will resume production once it has written notification from independent experts and the FDA that it is in compliance with the decree and regulations.