Ketorolac Tromethamine Inj — Class II drug recall D-926-2013
Terminated recall by Hospira, Inc., reported 2013-09-04. Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
| Recall number | D-926-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira, Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-10-28 |
| Quantity | 345,800 vials |
| Reason classes | sterility |
| NDC | 00409-3793, 00409-3793-01, 00409-3793-19, 00409-3793-25, 00409-3795, 00409-3795-01, 00409-3795-19, 00409-3795-25, 00409-3796, 00409-3796-01, 00409-3796-19, 00409-3796-25 |
| Lot numbers | 01/15, 25048DK |
Product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Reason for recall
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-926-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.