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Recall Observatory FDA recall evidence

Drug product

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11

D-0201-2025

January 07, 2025

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 96117
Status
Ongoing
Classification
Class II
Quantity
4640 units
Official record key
drug-enforcement:D-0201-2025

Official wording

Reason: Presence of Foreign Tablets/Capsules

Code information: Lot #: 1018598, Exp. Date 10/31/2025

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets