Romidepsin Injecton recall: Impurity Out of Spec
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
Why was Romidepsin Injecton recalled?
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 1,416 vials
- Distribution
- Distributed Nationwide in the USA.
- Recall date
- March 24, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)