Rocuronium Bromide Injection — Class II drug recall D-0099-2023
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2023-01-18, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0099-2023 |
|---|---|
| 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 | 2023-01-06 |
| Classified | 2023-01-09 |
| Reported by FDA | 2023-01-18 |
| Terminated | 2024-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 38,830 syringes |
| Reason classes | sterility |
| NDC | 69374-0924-05 |
| Lot numbers | RC2011A |
| Expiration dates | 2023-02-22 |
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
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-0099-2023. 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.