FDA Drug recall D-0446-2020
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc
- FDA Drug
- Class II
- completed
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0446-2020 |
| 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 Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | 17232 8/19 17334 11/19 18249 10/20 19125 4/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Other recalls by Altaire Pharmaceuticals
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FDA Drug · Class II · 2019-11-27 · Altaire Pharmaceuticals - CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc
FDA Drug · Class II · 2019-11-27 · Altaire Pharmaceuticals - CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15…
FDA Drug · Class II · 2019-11-27 · Altaire Pharmaceuticals - OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc
FDA Drug · Class II · 2019-11-27 · Altaire Pharmaceuticals - Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
FDA Drug · Class II · 2019-11-27 · Altaire Pharmaceuticals
All Altaire Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0446-2020%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.