Ketorolac Tromethamine Injection — Class II drug recall D-1354-2022
Terminated recall by Nephron Sc Inc, reported 2022-08-24, distributed nationwide. cGMP Deviations: deviations leading to potential cross-contamination.
| Recall number | D-1354-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sc Inc, West Columbia, SC, United States |
| Recall initiated | 2022-08-10 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2024-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 5,040 vials |
| Reason classes | cgmp |
| NDC | 00487-6232, 00487-6232-01 |
| Lot numbers | 023011 |
| Expiration dates | 2022-08-31 |
Product
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Reason for recall
cGMP Deviations: deviations leading to potential cross-contamination.
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-1354-2022. 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.