Tailstorm Health INC

FDA Inspection Triggers Nationwide Recall of Tailstorm Health's KETAmine Hydrochloride Injection Over Sterility Concerns

Tailstorm Health INC has initiated a Class II nationwide recall of 23,200 vials of KETAmine Hydrochloride Injection due to a lack of sterility assurance identified during an FDA inspection. This event, involving a critical compounded drug, signals heightened regulatory scrutiny on sterile manufacturing. Procurement and regulatory teams must immediately assess supply chain exposure, secure alternative sources, and reinforce robust quality oversight to mitigate patient safety risks and ensure continuity of care.