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Astellas Pharma US Inc. FDA Recalls

2 recalls on file across drugs, 2 of them Class I and 2 still open. Matched by name to ALPMY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Class IDec 23, 2024Failed Tablet/Capsule Specifications: Bottles shipped to the
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas PharmaClass IDec 23, 2024Failed Tablet/Capsule Specifications: Bottles shipped to the

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