FDA recall D-0309-2020
Lannett Company, Inc. · Class II · drug
Product
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-28
- Report date
- 2019-11-20
- Termination date
- 2021-04-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Philadelphia, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2020