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
Reported: March 24, 2021 Initiated: March 4, 2021 #D-0309-2021
Product Description
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
Reason for Recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 1,416 vials
- Distribution
- Distributed Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product 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. Recalled by Teva Pharmaceuticals USA. Units affected: 1,416 vials.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Low. Recall number: D-0309-2021.
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