Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hospira Inc., originally initiated on 01-23-2015 for the product KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 The product was recalled due to crystallization. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0482-2015 | 01-23-2015 | 04-15-2015 | Class II | HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 | Crystallization | Terminated |
| D-0483-2015 | 01-23-2015 | 04-15-2015 | Class II | HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials | KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 | Crystallization | Terminated |
Recalled Products
