KETOROLAC Tromethamine Inj — Class II drug recall D-0482-2015
Terminated recall by Hospira Inc., reported 2015-04-15, distributed nationwide. Crystallization
| Recall number | D-0482-2015 |
|---|---|
| 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, 00409-3795-49, 00409-3796, 00409-3796-01, 00409-3796-19, 00409-3796-25 |
| Lot numbers | 25-047-DK, 25-048-DK, 26-151-DK, 27-101-DK, 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, 29-556-DK, 29-557-DK, 35-229-DK, 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, 36-217-DK, 36-218-DK, 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, 38-141-DK, 38-143-DK, 39-014-DK, 39-104-DK, 40-301-DK, 40-534-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, 41-078-DK and 7 more |
| Expiration dates | 2015-01-01, 2015-02-01, 2015-03-01, 2015-04-01, 2015-05-01, 2015-11-01, 2015-12-01, 2016-01-01, 2016-02-01, 2016-03-01, 2016-04-01, 2016-05-01, 2016-06-01, 2016-09-01, 2016-10-01 |
Product
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
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-0482-2015. 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.