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.
Reported: February 5, 2025 Initiated: December 23, 2024 #D-0210-2025
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
Details
- Recalling Firm
- Astellas Pharma US Inc.
- Units Affected
- 3,500 30-count bottles
- Distribution
- Nationwide in the USA
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Astellas Pharma US Inc.. Units affected: 3,500 30-count bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2025. Severity: Critical. Recall number: D-0210-2025.
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