Drug recall
KETOROLAC TROMETHAMINE INJECTION, USP, 15 mg/mL, 25-count 1 mL SINGLE DOSE VIALS per carton, Rx Only, AMERICAN…
FDA recall event 53590 · Class I · Luitpold Pharmaceuticals, Inc.
Key facts
| Event ID | 53590 |
|---|---|
| Recall numbers | D-539-2010, D-540-2010, D-541-2010 |
| Recalling firm | Luitpold Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | KETOROLAC TROMETHAMINE INJECTION, USP, 15 mg/mL, 25-count 1 mL SINGLE DOSE VIALS per carton, Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967, NDC 0517-0601-25., KETOROLAC TROMETHAMINE INJECTION, USP, 30 mg/mL, 25-count 1 mL SINGLE DOSE VIALS per carton, Rx only; AMERICAN REGENT, INC. SHIRLEY, NY 11967, NDC 0517-0801-25., KETOROLAC TROMETHAMINE INJECTION, USP, 60 mg/2 mL (30 mg/mL), 25-count 2 mL SINGLE DOSE VIALS per carton, Rx only; AMERICAN REGENT, INC. SHIRLEY, NY 11967, NDC 0517-0902-25. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Firm observed particles in some retain vials of Ketorolac Tromethamine Injection, USP, 30 mg/mL & 15mg/mL. |
| Initiation date | Oct 16, 2009 |
| Termination date | Oct 17, 2012 |
| City | Shirley |
| State | NY |
| Country | United States |
| FEI number | 2410375 |
At a glance
- 1–9 Products in this recall
- 10–99 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