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Recall Observatory FDA recall evidence

Drug product

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

D-0650-2022

March 04, 2022

Class II

Product summary

Firm
Direct Rx
Event
Event 89749
Status
Terminated
Classification
Class II
Quantity
16 bottles
Official record key
drug-enforcement:D-0650-2022

Official wording

Reason: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Code information: Lot #: 19AU1910 Exp. 5/31/22

Distribution pattern: FL, GA, LA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations