FDA-Drug2025-02-05Class I

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.

Astellas Pharma US Inc.
Hazard

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Sold states
Nationwide in the USA
Affected count
14,340 100-count bottles
Manufactured in
2375 Waterview Dr, Northbrook, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0211-2025

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