Teva Pharmaceuticals USA: Drug Recall
Recall #D-0309-2021 · 03/04/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0309-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 03/04/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,416 vials
Reason for Recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
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
Distribution Pattern
Distributed Nationwide in the USA.
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/18/2022
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.