FDA recall D-0436-2020
Altaire Pharmaceuticals, Inc. · Class II · drug
Product
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
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-0436-2020