FDA recall D-1028-2020

Product

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82

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-1028-2020