FDA Drug recall D-0973-2015
Ketorolac Tromethamine Inj
- FDA Drug
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Ketorolac Tromethamine Inj by Hospira, citing crystallization.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0973-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
Reason
Crystallization
Identifiers
| code_info | Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016; Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016; Lots 44-357-DK, 44-358-DK…Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016; Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016; Lots 44-357-DK, 44-358-DK Exp. Date 1AUG2016; Lot 46-308-DK Exp. Date 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 38-137-DK Exp. Date 1FEB2016 - Note: The lot number may be followed by additional numbers from 01 to 99 |
|---|
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-0973-2015%22
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