Norepinephrine Bitartrate in 0 — Class II drug recall D-0357-2023
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2023-03-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0357-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sterile Compounding Center LLC, West Columbia, SC, United States |
| Recall initiated | 2023-02-22 |
| Classified | 2023-02-27 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 305,895 bottles |
| Reason classes | sterility |
| NDC | 69374-0319-25 |
| Lot numbers | 05/22/20123, NB2017A, NB2019A, NB2024A, NB2025A, NB2027A, NB2035A, NB2038A, NB2045A, NB2053A, NB2058B, NB2064A, NB2069A, NB2071A |
| Expiration dates | 2023-02-21, 2023-03-04, 2023-03-24, 2023-03-27, 2023-04-07, 2023-06-02, 2023-06-25, 2023-07-29, 2023-08-16, 2023-09-07, 2023-09-25, 2023-10-01 |
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
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-0357-2023. 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.