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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

D-1509-2014

July 25, 2014

Class II

Product summary

Firm
Sandoz Incorporated
Event
Event 68900
Status
Terminated
Classification
Class II
Quantity
1,332 bottles
Official record key
drug-enforcement:D-1509-2014

Official wording

Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Code information: Lot EJ9591

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance