Drug recall
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25…
FDA recall event 87082 · Class I · Fresenius Kabi USA, LLC
Key facts
| Event ID | 87082 |
|---|---|
| Recall numbers | D-0245-2021 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter - found in reserve sample vials at the firm. |
| Initiation date | Dec 23, 2020 |
| Report date | Feb 3, 2021 |
| Termination date | Jun 9, 2023 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3002733956 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: