FDA Drug recall D-0482-2015
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 --- ND…
- FDA Drug
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of 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 --- ND… by Hospira, citing crystallization.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0482-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-23 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Reason
Crystallization
Identifiers
| ndc | 0409-3793-19 |
|---|---|
| ndc | 0409-3793-01 |
| ndc | 0409-3793-25 |
| ndc | 0409-3795-19 |
| ndc | 0409-3795-01 |
| ndc | 0409-3795-25 |
| ndc | 0409-3796-19 |
| ndc | 0409-3796-01 |
| ndc | 0409-3796-25 |
| ndc | 0409-3795-49 |
| code_info | NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015; Lot number 26-151-DK, Exp. Date:1FEB2015; Lot n…NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015; Lot number 26-151-DK, Exp. Date:1FEB2015; Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015; Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015; Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015; Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015; Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016; Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016; Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016; Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016; Lot number: 41-078-DK, Exp. Date:1MAY2016; Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016; Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016; Lot number: 46-043-DK, 46-044-DK, 46-047-DK, Exp. Date:1OCT2016 AND NOVAPLUS LABEL NDC 0409-3795-49, Lot numb |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0482-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.