Drug product
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
D-0739-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,100 vials
- Official record key
drug-enforcement:D-0739-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31329045B, exp. date 07/2021; 31329077B, exp. date 08/2021; 31329312B, exp. date 09/2021
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility