FDA-Drug2021-03-24Class III
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
Hazard
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Sold states
Distributed Nationwide in the USA.
Affected count
1,416 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2021Don't want to check this manually?
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