Direct Rx: Drug Recall

Recall #D-0508-2023 · 03/22/2023

Class II: Risk

Recall Details

Recall Number: D-0508-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Direct Rx
Status: Ongoing
Date Initiated: 03/22/2023
Location: Dawsonville, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 349 bottles

Reason for Recall

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

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Direct Rx

Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 01/31/2025

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II: Risk 08/09/2024

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II: Risk 03/22/2023

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

View all recalls by Direct Rx →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.