Ketorolac Tromethamine Injection — Class I drug recall D-0245-2021
Terminated recall by Fresenius Kabi USA, LLC, reported 2021-02-03, distributed nationwide. Presence of Particulate Matter - found in reserve sample vials at the firm.
| Recall number | D-0245-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-12-23 |
| Classified | 2021-01-27 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2023-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 945,425 vials |
| Reason classes | specification failure |
| NDC | 63323-0161, 63323-0161-00, 63323-0161-01, 63323-0162, 63323-0162-00, 63323-0162-01, 63323-0162-02, 63323-0162-03, 63323-0162-11, 63323-0162-51 |
| Lot numbers | 6121083 |
| Expiration dates | 2021-02 |
Product
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
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-0245-2021. 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.