FDA Drug recall D-0444-2020
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd
- FDA Drug
- Class II
- completed
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0444-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-07-02 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Altaire Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 17198, Exp 7/19; 17199, Exp 7/19; 17233, Exp 8/19; 17337, Exp 11/19; 17338, Exp 11/19; 18248, Exp 10/20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.