Drug 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.
D-0210-2025
Product summary
- Event
- Event 96008
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3,500 30-count bottles
- Official record key
drug-enforcement:D-0210-2025
Official wording
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Code information: Lot# 0R3092A, EXP 03/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules