FDA recall D-0508-2023

Product

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

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-0508-2023