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Recall Observatory FDA recall evidence

Drug product

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

D-0602-2021

May 05, 2021

Class II

Product summary

Firm
Oxford Pharmaceuticals, LLC
Event
Event 87873
Status
Completed
Classification
Class II
Quantity
6,864 bottles
Official record key
drug-enforcement:D-0602-2021

Official wording

Reason: Presence of Foreign Tablets/Capsules

Code information: Lot #: C21021A, Exp. 03/2023

Distribution pattern: USA Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets