Reported Mar 24, 2021 · Terminated
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
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
Romidepsin Injecton27.5 mg/5.5 mL (5 mg/mL) Rx Only5.5 ml vialTeva Pharmaceuticals USAInc. NDC 0703-4004-01
- Lot codes and dates
Lot # 31328184Cexp. date 11/2021 Lot # 31327686Cexp. date 08/2021 Lot # 31327685Cexp. date 08/2021
- Amount recalled
- 1,416 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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