FDA recall D-0444-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide

Key facts

Status: Completed
Initiation date: 2019-07-02
Report date: 2019-11-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Aquebogue, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2020