Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Recall Number: D-0309-2021
Firm: Teva Pharmaceuticals USA
Classification: Class III
Status: Terminated
Report Date: 20210324
Initiation Date: 20210304
Termination Date: 20220519
Reason for Recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Product Description
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01