March 2021 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0309-2021 - Failed Impurity/Degradation Specifications
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 4, 2021 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0309-2021
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
03-04-2021
03-24-2021
1,416 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA.
05-19-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 31328184C, exp. date 11/2021
Lot# 31327686C, exp. date 08/2021
Lot# 31327685C, exp. date 08/2021
