Drug product
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
D-0211-2025
Product summary
- Event
- Event 96008
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 14,340 100-count bottles
- Official record key
drug-enforcement:D-0211-2025
Official wording
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Code information: Lot# 0E3353D, 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