Class III
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- March 4, 2021
- Posted
- March 24, 2021
- Recall Number
- D-0309-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,416 vials
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Distribution
Distributed Nationwide in the USA.
Lot / Code Info
Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
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