Astellas Pharma US recalls
FDA enforcement reports naming Astellas Pharma US Inc as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 2
- Most recent report
- Feb 5, 2025
- Feb 5, 2025Astagraf XL (tacrolimus extended-release capsules) 0Drug · Astellas Pharma US Inc.Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsulesClass I
- Feb 5, 2025Prograf (tacrolimus) capsules, USP, 0Drug · Astellas Pharma US Inc.Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsulesClass I
- Feb 14, 2018Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by:…Drug · Astellas Pharma US IncLabeling: Label Error on Declared StrengthClass II
- Oct 15, 2014Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremer…Drug · Astellas Pharma US IncFailed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.Class II
- Jul 31, 2013AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intra…Drug · Astellas Pharma US IncLack 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…Class II