FDA recall D-0795-2020

Denton Pharma, Inc. · Class II · drug

Product

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-12-20
Report date: 2020-01-29
Termination date: 2023-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Blenheim, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0795-2020