FDA recall D-0016-2021

Direct Rx · Class II · drug

Product

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

FL, GA

Key facts

Status: Terminated
Initiation date: 2020-01-15
Report date: 2020-10-14
Termination date: 2020-12-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2021