FDA recall D-0794-2020

Product

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), 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-0794-2020