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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10

D-1515-2014

July 30, 2014

Class II

Product summary

Firm
Mckesson Packaging Services
Event
Event 68946
Status
Terminated
Classification
Class II
Quantity
1240 boxes/124,000 tablets
Official record key
drug-enforcement:D-1515-2014

Official wording

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

Code information: Lot 102492, exp 01/2016

Distribution pattern: CO & OH

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance