OCuSOFT Tetravisc Forte Tetracaine HCl 0 recalled over sterility concerns

Recall date

July 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Altaire Pharmaceuticals, Inc. recalls OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77…

Recall number

D-0444-2020

FDA classification

Class II

Brand / firm

Altaire Pharmaceuticals, Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05