Drug Enforcement D-0210-2025

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Status

Ongoing

Classification

Class I

Report Date

February 5, 2025

Termination Date

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Product Information

Product description
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Product quantity
3,500 30-count bottles
Reason for recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Astellas Pharma US Inc.
Address
2375 Waterview Dr

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

Codes & Dates

Recall number
D-0210-2025
Event ID
96008
Recall initiation date
December 23, 2024
Center classification date
January 29, 2025
Code info
Lot# 0R3092A, EXP 03/31/2026
More code info
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