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Recall Observatory FDA recall evidence

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.

D-0509-2023

March 22, 2023

Class II

Product summary

Firm
Direct Rx
Event
Event 92054
Status
Ongoing
Classification
Class II
Quantity
9 bottles
Official record key
drug-enforcement:D-0509-2023

Official wording

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

Code information: Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations