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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

D-0186-2020

October 23, 2019

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 84080
Status
Terminated
Classification
Class II
Quantity
5,760 bottles
Official record key
drug-enforcement:D-0186-2020

Official wording

Reason: Presence of Foreign Substance

Code information: Lot #: 8082708, Exp. Date September 2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance