Recall archive / FDA drug enforcement
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Ma... — FDA record D-0371-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 31, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 11,450 vials
- Agency-reported status
- Terminated
- Source record identifier
- D-0371-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 100020800, exp 07/2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 19, 2022
- Recall initiation date
- Dec 31, 2021
- Center classification date
- Jan 13, 2022
- Termination date
- Jun 4, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.