FDA recall D-0798-2020

Product

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

Reason for recall

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Distribution

Product was distributed to two facilities in CA and NY.

Key facts

Status

Terminated

Initiation date

2019-12-11

Report date

2020-01-29

Termination date

2020-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2020