Drug product
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
D-0371-2022
Product summary
- Event
- Event 89326
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,450 vials
- Official record key
drug-enforcement:D-0371-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 100020800, exp 07/2022
Distribution pattern: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility