FDA recall D-1854-2019
Compounded Solutions in Pharmacy · Class II · drug
Product
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Reason for recall
Lack of Processing Controls:
Distribution
Product was dispensed to patients
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-03
- Report date
- 2019-09-18
- Termination date
- 2020-03-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Monroe, CT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1854-2019