FDAFDA · Food and drugs·Recall number D-0309-2021
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
Published March 24, 2021 · Recall initiated: March 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Distributed Nationwide in the USA.
- Lot
- Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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