FDA Drug recall D-0184-2021
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zuri…
- FDA Drug
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zuri… by Fresenius Kabi Usa, citing presence of Particulate Matter - found in reserve sample vials at the firm.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0184-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Identifiers
| ndc | 63323-161-00 |
|---|---|
| ndc | 63323-161-01 |
| ndc | 63323-162-11 |
| ndc | 63323-162-51 |
| ndc | 63323-162-00 |
| ndc | 63323-162-01 |
| ndc | 63323-162-03 |
| ndc | 63323-162-02 |
| code_info | Batch # 6121125, Exp 02/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0184-2021%22
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