FDA recall D-0453-2020
Altaire Pharmaceuticals, Inc. · Class II · drug
Product
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
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-0453-2020