Ketorolac Tromethamine INJECTION — Class II drug recall D-0027-2015
Terminated recall by Sagent Pharmaceuticals Inc, reported 2014-10-22, distributed nationwide. Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of l
| Recall number | D-0027-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2014-10-03 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2016-02-23 |
| Distributed | Nationwide (US) |
| Quantity | 69,050 vials |
| Reason classes | labeling |
| NDC | 25021-0700, 25021-0700-01, 25021-0701, 25021-0701-01, 25021-0701-02 |
| Lot numbers | 04/16, 05/16, MP5021, MP5024, MP5025 |
Product
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
Reason for recall
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
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-0027-2015. 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.