Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84149

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 28, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Lannett Company, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80

D-0309-2020
Recall number
D-0309-2020
Initiated
October 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Lannett Company, Inc.
Quantity
683,149 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Code information

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 01/2021 2019A 01/2021 2020A 01/2021 2065A 03/2021 2066A 03/2021 2067A 03/2021 2071A 03/2021 2072A 03/2021 2073A 03/2021 2076A 03/2021 2077A 03/2021 2078A 03/2021 2126A 05/2021 2127A 05/2021 2128A 05/2021 2164A 06/2021 2165A 06/2021 2166A 06/2021 2179A 06/2021 2180A 07/2021 2181A 07/2021 2214A 08/2021 2215A 08/2021 2216A 08/2021

Distribution pattern

Nationwide