Teva Pharmaceuticals USA recalls 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
Recalled March 24, 2021 · FDA recall D-0309-2021 · Teva Pharmaceuticals USA
Hazard
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. · FDA Class III
Units
1,416 vials
Sold at
Distributed Nationwide in the USA.
Description
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Product
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →