Astellas Pharma US Inc

FDA Regulatory Profile

Summary

Total Recalls
5 (2 Class I)
510(k) Clearances
0
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0211-2025Class IPrograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, DistributedDecember 23, 2024
D-0210-2025Class IAstagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of JapDecember 23, 2024
D-0548-2018Class IIMycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas PharJanuary 22, 2018
D-0008-2015Class IITarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban PharmSeptember 15, 2014
D-820-2013Class IIAmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous InfusiJune 19, 2013