D-0210-2025 Class I Ongoing
FDA drug recall D-0210-2025 was initiated by Astellas Pharma US Inc. on December 23, 2024 and is designated Class I. Reason for recall: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules The recall status is ongoing. Affected quantity: 3,500 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2025
- Initiation Date
- December 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,500 30-count bottles
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 0R3092A, EXP 03/31/2026