Ketorolac Tromethamine Inj — Class II drug recall D-0388-2015
Terminated recall by Hospira Inc., reported 2015-02-25, distributed nationwide. Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
| Recall number | D-0388-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2015-02-13 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2016-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 100 vials |
| Reason classes | temperature control |
| 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 | 34-540-DK |
| Expiration dates | 2015-10-01 |
Product
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
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-0388-2015. 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.