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Recall Observatory FDA recall evidence

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

March 04, 2021

Class III

Product summary

Firm
Teva Pharmaceuticals USA
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurity/Degradation Specifications