FDA recall D-0613-2020

Amneal Pharmaceuticals, Inc. · Class II · drug

Product

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Reason for recall

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

Distribution

Product was distributed throughout the United States.

Key facts

Status: Ongoing
Initiation date: 2019-11-22
Report date: 2019-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2020