FDA recall D-1013-2020

Product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;

Reason for recall

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-10-23

Report date

2020-03-25

Termination date

2020-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1013-2020