FDA recall D-0477-2023

Direct Rx · Class II · drug

Product

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Reason for recall

cGMP deviations

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2023-03-13
Report date
2023-04-05
Termination date
2024-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2023