Teva Pharmaceuticals USA recalls 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
- Recall date
- March 4, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0309-2021
- FDA classification
- Class III
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Distributed Nationwide in the USA.
Why it was recalled
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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