Drug product
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
D-0734-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,091 vials
- Official record key
drug-enforcement:D-0734-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31328668B, exp. date 04/2023
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility