KETOROLAC Tromethamine Inj — Class II drug recall D-0483-2015
Terminated recall by Hospira Inc., reported 2015-04-15, distributed nationwide. Crystallization
| Recall number | D-0483-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-01-23 |
| Classified | 2015-04-08 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2016-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | SG |
| 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, 00409-3796-49 |
| Lot numbers | 26-097-DK, 26-098-DK, 29-239-DK, 29-240-DK, 34-540-DK, 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, 41-282-DK, 41-284-DK, 44-076-DK, 45-240-DK, 46-306-DK |
| Expiration dates | 2015-02-01, 2015-05-01, 2015-10-01, 2016-01-01, 2016-05-01, 2016-08-01, 2016-09-01, 2016-10-01 |
Product
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason for recall
Crystallization
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-0483-2015. 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.