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Astellas Pharma US Recalls
5 recalls on record · July 31, 2013 to February 5, 2025 · Drugs
Recalls by year
13
14
18
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 5, 2025DrugsFDA
Astellas Pharma US Inc. recalls Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma
Hazard: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
February 5, 2025DrugsFDA
Astellas Pharma US Inc. recalls Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:
Hazard: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
February 14, 2018DrugsFDA
Astellas Pharma US Inc recalls Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbro
Hazard: Labeling: Label Error on Declared Strength
October 15, 2014DrugsFDA
Astellas Pharma US Inc recalls Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seym
Hazard: Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
July 31, 2013DrugsFDA
Astellas Pharma US Inc recalls AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Ma
Hazard: Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.