FDA recall D-0137-2023
Akorn, Inc. · Class II · drug
Product
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
Reason for recall
CGMP Deviations:
Distribution
Nationwide in the USA
Key facts
- Status
- Ongoing
- Initiation date
- 2022-10-13
- Report date
- 2023-01-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Gurnee, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2023