Recall D-0210-2025

US Class I Ongoing · initiated 2024-12-23

Recalling firm

Astellas Pharma US Inc., IL

Product

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.

Reason for recall

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

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