PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: April 12, 2023 Initiated: March 22, 2023 #D-0508-2023

Product Description

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.

Details

Recalling Firm
Direct Rx
Units Affected
349 bottles
Distribution
Nationwide in the USA
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Direct Rx. Units affected: 349 bottles.
Why was this product recalled?
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0508-2023.