FDAHealthDecember 23, 2024
Astellas Pharma US Inc. — 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.
⚠️ Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 23, 2024
Nationwide in the USA
What's affected?
- 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.
- Brand
- PROGRAF
- UPC
- 0304690607731
- Lot code
- 0E3353D
Additional details
Lot# 0E3353D, Exp 03/31/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 14,340 100-count bottles.
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