FDA Drug recall D-0309-2020
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc
- FDA Drug
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc by Lannett, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0309-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-28 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
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
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | 1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019…1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020 1646A 02/2020 1647A 02/2020 1668A 03/2020 1669A 03/2020 1670A 03/2020 1708A 03/2020 1709A 04/2020 1710A 04/2020 1729A 04/2020 1730A 04/2020 1731A 04/2020 1757A 05/2020 1758A 05/2020 1759A 05/2020 1773A 06/2020 1774A 06/2020 1989A 12/2020 1794A 06/2020 1795A 06/2020 1796A 06/2020 1817A 06/2020 1818A 07/2020 1819A 07/2020 1840A 08/2020 1840B 08/2020 1841A 08/2020 1842A 08/2020 1863A 08/2020 1864A 09/2020 1865A 09/2020 1899A 10/2020 1900A 10/2020 1901A 10/2020 1910A 10/2020 1911A 10/2020 1912A 10/2020 1918A 10/2020 1919A 10/2020 1920A 10/2020 1925A 10/2020 1926A 10/2020 1927A 10/2020 1977A 12/2020 1978A 12/2020 1979A 12/2020 1990A 12/2020 1991A 12/2020 1998A 01/2021 1999A 01/2021 2000A 01/2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0309-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.