FDA recall D-0509-2023

Direct Rx · Class II · drug

Product

Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.

Reason for recall

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2023-03-22
Report date
2023-04-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2023