FDA recall D-0478-2023

Product

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

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-0478-2023