FDA recall D-1015-2020

Product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47

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-1015-2020