Drug Enforcement D-0460-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 18, 2025

Termination Date

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Product Information

Product description
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Product quantity
3,817 50-count cartons
Reason for recall
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0460-2025
Event ID
96888
Recall initiation date
May 13, 2025
Center classification date
June 9, 2025
Code info
Lot #47881, Exp 05/31/2026
More code info
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