Drug 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
D-0309-2021
Product summary
- Event
- Event 87452
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,416 vials
- Official record key
drug-enforcement:D-0309-2021
Official wording
Reason: Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Code information: Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications