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Recall Observatory FDA recall evidence

Drug product

Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15

D-0460-2025

May 13, 2025

Class II

Product summary

Firm
AvKARE
Event
Event 96888
Status
Ongoing
Classification
Class II
Quantity
3,817 50-count cartons
Official record key
drug-enforcement:D-0460-2025

Official wording

Reason: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Code information: Lot #47881, Exp 05/31/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets