FDA recall D-0646-2020

Product

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Distribution

Product was distributed to one consignee who may have distributed the product further to their retail stores.

Key facts

Status

Terminated

Initiation date

2019-12-26

Report date

2020-01-15

Termination date

2021-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lumberton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2020