Oxytocin 30 Units/500 mL — Class II drug recall D-0964-2022
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2022-06-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0964-2022 |
|---|---|
| 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 | 2022-05-18 |
| Classified | 2022-05-27 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2024-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 3,587 bags |
| Reason classes | sterility |
| NDC | 69374-0543-50 |
| Lot numbers | OX2008C, OX2010C, OX2011C, OX2011D |
| Expiration dates | 2022-05-27, 2022-06-17, 2022-06-24 |
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
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-0964-2022. 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.