Recalls / Class III
Class IIID-0309-2021
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
- Affected lot / code info
- Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
Why it was recalled
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1,416 vials
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2021-03-04
- FDA classified
- 2021-03-19
- Posted by FDA
- 2021-03-24
- Terminated
- 2022-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0309-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.