FDA Drug recall D-926-2013
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
- FDA Drug
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 by Hospira, citing lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-926-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-12 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | n/a |
Product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Reason
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
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 |
| code_info | Lot 25048DK Exp. 01/15 |
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-926-2013%22
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