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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

D-0567-2022

February 15, 2022

Class II

Product summary

Firm
ANI Pharmaceuticals, Inc.
Event
Event 89556
Status
Terminated
Classification
Class II
Quantity
70,788 bottles
Official record key
drug-enforcement:D-0567-2022

Official wording

Reason: cGMP Deviations

Code information: Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations