The FDA this week attacked several companies involved in an eye wash and a skin cream without FDA authorization. The FDA stated that these prescription medications could cause risks to patients.
Balanced salt solution is an eye wash which is used to keep the eyes moist. Two companies, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the FDA, and are not affected by this crackdown.
But B. Braun, Baxter and Hospira firms are selling similar types of eye wash without federal validation of their safety and effectiveness.
The skin cream which contains an enzyme called papain, is used for treating skin ulcers for example from diabetes.
The FDA said it has received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams, including some that said the ointment was of no help to patients and others describing life-threatening allergic reactions.
Legal Analysis: I wonder who blew the whistle on these companies?