FDAHealthDecember 23, 2024
Astellas Pharma US Inc. — 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 046
⚠️ 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
- 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.
- Brand
- ASTAGRAF XL
- Lot code
- 0R3092A
Additional details
Lot# 0R3092A, EXP 03/31/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 3,500 30-count bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.