Norepinephrine Bitartrate Injection USP 4 mg/4 mL — Class II drug recall D-0371-2022
Terminated recall by Teva Pharmaceuticals USA, reported 2022-01-19, distributed in MS, OH, TN. Lack of Assurance of Sterility
| Recall number | D-0371-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-12-31 |
| Classified | 2022-01-13 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-06-04 |
| Distributed | MS, OH, TN |
| Quantity | 11,450 vials |
| Reason classes | sterility |
| NDC | 00703-1153-03 |
| Lot numbers | 100020800 |
| Expiration dates | 2022-07 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0371-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.