FDA Issues Warning About Unapproved Ophthalmic Balanced Salt Solution Drug Products

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Written by Sheldon S. Sones, RPh, FASCP

Wednesday, 01 October 2008

It appears that the FDA is requiring certain manufacturers of balanced salt solutions (BSS) to cease and desist from manufacturing these products on or before November 24, 2008. You can read the FDA release here. If you use these products, the only “approved” manufacturers, as of this article (published Oct. 1, 2008), are Alcon and Akorn.

You should develop an action plan to secure these products — at this time — from your Alcon or Akorn BSS sources. From the bulletin, the issue relates to licensure and not specific lot numbers of the products from “unapproved companies.”

Acceptable manufacturers and NDA numbers are:

Alcon NDA BSS #20-742
Alcon NDA BSS Plus #18-469
Akorn NDA #75-503
Akorn Endosol Extra NDA# 20-079

Note: This article comes from a recent edition of Pharm-ASC, a weekly e-mail publication by Sheldon S. Sones, RPh, FASCP, a Newington, Conn.-based consultant, pharmacist and safe medication officer serving more than 100 ASCs in the Northeast. Learn more at www.sheldonsones.com.