FDA recall D-0397-2020
Altaire Pharmaceuticals, Inc. · Class II · drug
Product
Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15
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-0397-2020