FDA recall D-0173-2020

Product

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Product was distributed to major distributors throughout the United States who may have further distributed the product.

Key facts

Status

Completed

Initiation date

2019-10-01

Report date

2019-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2020