D-0309-2021 Class III Terminated
FDA drug recall D-0309-2021 was initiated by Teva Pharmaceuticals USA on March 4, 2021 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. The recall status is terminated (terminated May 19, 2022). Affected quantity: 1,416 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- March 4, 2021
- Termination Date
- May 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,416 vials
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
Reason for Recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021