FDA recall D-0309-2021

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

Reason for recall

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

Distribution

Distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2021-03-04

Report date

2021-03-24

Termination date

2022-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2021