Ketorolac Tromethamine Inj — Class II drug recall D-0972-2015
Terminated recall by Hospira Inc., reported 2015-05-06, distributed nationwide. Crystallization
| Recall number | D-0972-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-04-28 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2017-12-04 |
| Distributed | Nationwide (US) |
| NDC | 00409-3795-49 |
| Lot numbers | 35-230-DK, 35-231-DK, 35-235-DK, 35-507-DK, 36-136-DK, 37-146-DK, 38-138-DK, 39-103-DK, 39-255-DK, 40-535-DK, 40-539-DK, 40-549-DK, 41-079-DK, 42-252-DK, 42-254-DK, 43-262-DK, 43-263-DK, 45-031-DK, 45-032-DK, 45-033-DK, 46-001-DK |
| Expiration dates | 2015-11-01, 2015-12-01, 2016-01-01, 2016-02-01, 2016-03-01, 2016-04-01, 2016-05-01, 2016-06-01, 2016-07-01, 2016-09-01, 2016-10-01 |
Product
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
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-0972-2015. 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.